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MACI autologous cultured chondrocytes 15000000 1/1; 15 cm2/1 Implant, 1 implant — NDC 69866-1030-05 package photo

MACI autologous cultured chondrocytes 15000000 1/1; 15 cm2/1 Implant, 1 implant

by Vericel Corporation · 1 BAG in 1 BOX (69866-1030-5) / 1 BOTTLE, PLASTIC in 1 BAG (69866-1030-4) / 1 IMPLANT in 1 BOTTLE, PLASTIC (69866-1030-3)
NDC 69866-1030-05
🏷️ FDA NDC (as labeled) 69866-1030-5 billing pads the package segment with a zero
This package
Contains1 implant Pack sizes2 compare ↓
Also comes in: 1 implant 69866-1030-08
Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 69866-1030-5
Product NDC 69866-1030
11-digit billing NDC 69866103005
NCPDP billing unit EA — each (per item)
UNII D5P3K3V822, I8442U2G7J
Application # BLA125603
SPL Set ID 0c336c02-8c4c-4aa8-a992-9d2890a2539c
Established class (EPC) Autologous Cultured Cell
Chemical class Chondrocytes
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-06-09
Route INTRA-ARTICULAR
Dosage form IMPLANT
Substance AUTOLOGOUS CULTURED CHONDROCYTES; PORK COLLAGEN
GPI-14 75840015209100
GPI class MACI
GCN Seq No 076989
GCN 42853
HICL code 044023
Ingredient (HICL) Autol Chrondrocy/Collagen,Porc
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S1
Therapeutic class — intermediate (HIC2) Cultured Tissue-Human
HIC3 code S1A
Therapeutic class — specific (HIC3) Joint Tissue Replacement
AHFS code 92:92.00.00
AHFS class Other Miscellaneous Therapeutic Agents
FDB label name MACI 3CM X 5CM IMPLANT SHEET
FDB brand name Maci
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 69866-1030-5 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 69866-1030-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerVericel Corporation
FDA applicationBLA125603 (BLA)
Labeler code69866
First marketedJun 2017
Product typeCellular Therapy
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MACI 3CM X 5CM IMPLANT SHEET Ingredient Autol Chrondrocy/Collagen,Porc

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 implant
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maci 15000000 1/1; 15 cm2this 69866-1030-05 Vericel 1 implant — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2016
First FDA approval
Dec 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2028. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 13, 2016 ⏳ ~2.2 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Carticel Sm ServiceAutologous Cultured Chondrocytes
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2016 2018 2020 2022 2024 2026 2028
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateDec 13, 2028
Common questions
Is there a biosimilar for MACI 3CM X 5CM IMPLANT SHEET?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for MACI (this brand).

Top reported reactions

Treatment Failure35
Arthralgia27
Graft Delamination23
Pain22
Transplant Failure18
Procedural Pain12
Product Quality Issue8

Reporter sex

449 reports
Male · 46%
Female · 54%

Serious outcomes

Hospitalization8
Disabling4
Death3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 39 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69866-1030-05 You're viewing this 1 BAG in 1 BOX (69866-1030-5) / 1 BOTTLE, PLASTIC in 1 BAG (69866-1030-4) / 1 IMPLANT in 1 BOTTLE, PLASTIC (69866-1030-3) 2017-06-09 Active
69866-1030-08 2 BAG in 1 BOX (69866-1030-8) / 1 BOTTLE, PLASTIC in 1 BAG (69866-1030-7) / 1 IMPLANT in 1 BOTTLE, PLASTIC (69866-1030-6) 2017-06-09 Active

Pack size FAQ

What quantity is in NDC 69866-1030-05?
NDC 69866-1030-05 contains 1 implant — 1 bag in 1 box / 1 bottle, plastic in 1 bag / 1 implant in 1 bottle, plastic.
What NDC number is used to bill for this package of MACI autologous cultured chondrocytes 15000000 1/1; 15 cm2/1 Implant?
Bill NDC 69866-1030-05 — the 11-digit billing format is 69866103005. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69866-1030-5, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69866-1030-05, written without dashes as 69866103005. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69866-1030-05, the first segment (69866) is the labeler code FDA assigned to Vericel Corporation; the middle segment (1030) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Vericel Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 implant (69866-1030-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Vericel Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 140 words ▾

1 INDICATIONS AND USAGE MACI ® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults. Limitations of Use Effectiveness of MACI in joints other than the knee has not been established. Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

MACI ® is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. ( 1 ) Limitations of Use Effectiveness of MACI in joints other than the knee has not been established. Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For Autologous Implantation Only. Contact Vericel at 1-800-453-6948 or www.MACI.com regarding training materials for surgical implantation of MACI. For autologous implantation only.

Contact Vericel at 1-800-453-6948 or www.MACI.com regarding training materials for surgical implantation of MACI. ( 2 ) The amount of MACI implanted depends on the size (surface area in cm 2 ) of the cartilage defect. ( 2.1 ) MACI should be cut to the size and shape of the defect and implanted with the cell-side down.

( 2.2 )

2.1Dosage The amount of MACI implanted depends on the size (surface area in cm 2 ) of the cartilage defect. The surgeon should cut the MACI implant to the size and shape of the defect, to ensure the damaged area is completely covered. MACI implant is for single-use. Multiple implants may be used if there is more than one defect. The size of MACI is adjusted for the size of each cartilage defect.

2.2Preparation and Implantation Procedure Collection of Autologous Cartilage Biopsy The procedure may be performed arthroscopically. Using a ring curette or curved notchplasty gouge, harvest at least two (2) healthy full-thickness cartilage specimens from a lesser load-bearing area of the damaged knee, such as the lateral intercondylar notch, the superior lateral trochlear ridge, or the superior medial trochlear ridge. The specimens should measure approximately 5 x 8 mm each (200-300 mg total).

The biopsy must be full-thickness and should include a small amount of subchondral bone, which will be removed prior to processing the biopsy. Some punctate bleeding may occur at the site of biopsy harvest. Using sterile technique, place the biopsy into transport medium bottle.

Pre-Operative Preparation Confirm that the patient’s identity matches the patient identifiers on the MACI labels. Inspect the sealed MACI shipping box for any evidence of damage. Open the MACI shipping box and inspect the internal packaging for leaks (liquid) in the outer bag or self-seal pouch containing the bottle holding the MACI implant or for any evidence of damage or contamination.

DO NOT USE if the patient identifiers do not match, or there are signs of leaking or damage to the packaging. Contact MACI representative immediately or call Vericel Customer Care at 1-800-453-6948. After inspection, keep MACI in its original packaging and store at room temperature until the surgical site has been prepared.

Arthroscopic delivery is for lesions that are a maximum of 4 cm 2 in size and are accessible using an arthroscopic approach. Implantation Procedure Perform implantation procedure during arthrotomy or arthroscopy using sterile surgical techniques. Follow the implantation with an appropriate, physician-prescribed rehabilitation program [see Dosage and Administration ( 2.3 )].

NOTE: The MACI Surgical Implantation Kit may be used to assist with MACI knee surgery via arthrotomy. The MACI Arthroscopic Instruments may be used to assist with arthroscopic delivery. Ensure instruments selected are appropriately matched to the defect size.

Preparing Defect Arthroscopic Delivery: Create an appropriately placed portal to to visualize the defect to be treated athroscopically. Under direct arthroscopic vision insert a spinal needle directly over the center of the cartilage defect. Use the location determined by the spinal needle to create a second portal for the cannula (e.g., MACI Cannula Assembly) directly perpendicular to the defect.

Measure the length and width of the defect using a measurement probe (e.g., measurement device) as shown in Figure 1 . Figure 1: Measure defect size – Arthroscopic Method Select and insert the appropriate size cannula (e.g., MACI Cannula Assembly) in this second portal directly over the center of the cartilage defect. Remove trocar from cannula assembly.

Select the appropriate size cutter (e.g., MACI Arthroscopic Cutter) based on the defect size. Insert the cutter through the cannula and position over the cartilage defect…

💊 Dosage Forms and Strengths 89 words ▾

3 DOSAGE FORMS AND STRENGTHS MACI implant is available as a cellular sheet, 3 x 5 cm, with a 0.5-cm 2 section removed from the lower left-hand corner, consisting of autologous cultured chondrocytes on a resorbable Type I/III collagen membrane at a density of at least 500,000 cells per cm 2 . Each 3 x 5 cm cellular sheet (MACI implant) consists of autologous cultured chondrocytes on a resorbable porcine Type I/III collagen membrane, at a density of at least 500,000 cells per cm 2 . ( 3 )

⛔ Contraindications 170 words ▾

4 CONTRAINDICATIONS MACI is contraindicated in patients with the following conditions: Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. [see Description ( 11 )] Severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4). Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. Prior knee surgery (6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.

Inability to cooperate with a physician-prescribed post-surgical rehabilitation program [See Dosage and Administration ( 2.3 )]. Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. ( 4 ) Severe osteoarthritis of the knee.

( 4 ) Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. ( 4 ) Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant. ( 4 ) Inability to cooperate with a physician-prescribed post-surgical rehabilitation program.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Malignancy: The risk of malignancy in the area of cartilage biopsy or implant is unknown. Expansion of malignant or dysplastic cells present in biopsy tissue during manufacture and subsequent implantation may be possible. ( 5.1 ) Transmissible infectious diseases: Because patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases, cartilage biopsy and MACI implant may carry risk of transmitting infectious diseases.

( 5.2 ) Presurgical Comorbidities: Local inflammation or active infection in the bone, joint, and surrounding soft tissue, meniscal pathology, cruciate ligament instability, and misalignment should be assessed and treated prior to or concurrent with MACI implantation. ( 5.3 ) Product Sterility: Final sterility test results are not available at the time of shipping. ( 5.4 )

5.1Malignancy The safety of MACI used in patients with malignancy in the area of cartilage biopsy or implant is unknown. The potential exists for expansion of malignant or dysplastic cells present in biopsy tissue during manufacture and subsequent implantation. In addition, implantation of normal autologous chondrocytes could theoretically stimulate growth of malignant cells in the area of the implant, although there have been no such incidents reported in humans or animals.

5.2Transmissible Infectious Diseases MACI is intended solely for autologous use. Patients undergoing the surgical procedures associated with MACI are not routinely tested for transmissible infectious diseases. Therefore, the cartilage biopsy and the MACI implant may carry the risk of transmitting infectious diseases to personnel handling these tissues.

Accordingly, healthcare providers should employ universal precautions in handling the biopsy samples and the MACI product. Product manufacture includes reagents derived from animal materials. All animal-derived reagents are tested for viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma before use.

Bovine materials are sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and may cause a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. These measures do not totally eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Report the occurrence of a transmitted infection to Vericel Corporation at 1-800-453-6948.

5.3Presurgical Assessment of Comorbidities To create a favorable environment for healing, assess and treat the following conditions prior to or concurrent with implantation with MACI: Local inflammation or active infection in the bone, joint, and surrounding soft tissue : patients should be deferred until complete recovery. Meniscal pathology : presence of an unstable or torn meniscus requires partial resection, repair, or replacement prior to or concurrent with MACI implantation. MACI is not recommended in patients with a total meniscectomy.

Cruciate ligament instability : the joint should not possess excessive laxity, which may create excessive shear and rotational forces across the joint. Both anterior and posterior cruciate ligaments should be stable or undergo reconstruction prior to or concurrent with MACI implantation. Misalignment : the tibio-femoral joint should be properly aligned, and patella tracking should be normalized.

Varus or valgus misalignment of the tibio-femoral joint and abnormal patella tracking may abnormally load joint surfaces and jeopardize the implant. Misalignment and patella tracking should be addressed with a corrective osteotomy or similar corrective procedure prior to or concurrent with MACI implantation.

5.4Product Sterility MACI is shipped after passing preliminary test results from in-process microbial tests. A final sterility test is initiated prior to shipping, but the result will not be available prior to implantation. If microbial contamination is detected after the pr…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most frequently occurring adverse reactions (≥5%) reported for MACI were arthralgia, tendonitis, back pain, joint swelling, and joint effusion. Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis. The most frequently occurring adverse reactions (≥5%) reported for MACI were arthralgia, tendonitis, back pain, joint swelling, and joint effusion.

( 6 ) Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Vericel at 1-800-453-6948 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice. In a 2-year prospective, multicenter, randomized, open-label, parallel-group clinical trial, 144 patients, ages 18 to 54 years, were randomized to receive a 1-time treatment with MACI or microfracture (1:1, 72 patients in each treatment group).

Demographic characteristics of patients in the trial were similar in both treatment groups. The majority of patients were male (62.5% MACI, 66.7% microfracture), and the mean ages were 34.8 (MACI) and 32.9 (microfracture) years. Overall, 70 patients in the MACI group and 67 patients in the microfracture group completed 2 years of follow-up.

In addition, all 144 subjects from the 2-year clinical trial had the option to enroll in a 3-year follow-up study (extension study). Safety and efficacy assessments were performed at yearly scheduled visits. The demographic characteristics of patients (N = 128) enrolled in the extension study were similar in both treatment groups and consistent with the overall population of the 2-year clinical trial.

The proportion of patients with at least one (1) subsequent surgical procedure (any surgical procedure performed on the treated knee joint, including arthroscopy, arthrotomy, or manipulation under anesthesia) in the 2 years following study treatment was comparable between treatment groups (8.3% in the MACI group and 9.7% in the microfracture group). Adverse reactions reported in ≥5% of patients in either treatment group in the 2-year clinical trial are provided in Table 1 . Table 1.

Adverse Reactions in ≥5% of Patients in Any Treatment Group in the 2-Year Clinical Trial System Organ Class MACI n = 72 n (%) Microfracture n = 72 n (%) Musculoskeletal and Connective Tissue Disorders Arthralgia 37 (51.4) 46 (63.9) Back pain 8 (11.1) 7 (9.7) Joint swelling 7 (9.7) 4 (5.6) Joint effusion 5 (6.9) 4 (5.6) Injury, Poisoning and Procedural Complications Cartilage injury 3 (4.2) 9 (12.5) Ligament sprain 3 (4.2) 5 (6.9) Procedural pain 3 (4.2) 4 (5.6) General Disorders and Administration Site Conditions Treatment failure 1 (1.4) 4 (5.6) In the 3-year extension study, adverse reactions reported in ≥5% of patients were (MACI vs microfracture): arthralgia (46.2% vs 50.8%), tendonitis (6.2% vs 1.6%), back pain (4.6% vs 6.3%), osteoarthritis (4.6% vs 7.9%), joint effusion (3.1% vs 7.9%), cartilage injury (6.2% vs 15.9%), procedural pain (3.1% vs 7.9%), ligament sprain (1.5% vs 7.9%), and treatment failure (4.6% vs 7.9%).

Serious adverse reactions reported in patients in either treatment group for integrated data across the 2-year clinical trial and the 3-year extension study are provided in Table 2 . Table 2. Serious Adverse Reactions in Patients in Any Treatment Group Across the 2-Year Clinical Trial and the 3-Year Extension Study System Organ Class MACI n = 72 n (%) Microfracture n = 72 n (%) Musculoskeletal and Connective Tissue Disorders Arthralgia 1 (1.4) 7 (9.7) Back pain 0 3 (4.2) Joint swelling 3 (4.2) 0 Joint effus…

👥 Use in Specific Populations 211 words ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Because MACI implantation requires invasive surgical procedures, use in pregnancy is not recommended. ( 8.1 )

8.1Pregnancy Risk Summary MACI implantation requires invasive surgical procedures; therefore use during pregnancy is not recommended. Limited clinical data on patients exposed to MACI during pregnancy are available. There are insufficient data with MACI use in pregnant women to inform a product-associated risk.

Animal reproduction studies have not been conducted with MACI. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of MACI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MACI and any potential adverse effects on the breastfed infant from MACI or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of MACI in pediatric patients have not been established.

8.5Geriatric Use The safety and effectiveness of MACI in patients over 65 years of age have not been established. Clinical trials of MACI did not include subjects over the age of 55.

🤰 Pregnancy 77 words ▾

8.1Pregnancy Risk Summary MACI implantation requires invasive surgical procedures; therefore use during pregnancy is not recommended. Limited clinical data on patients exposed to MACI during pregnancy are available. There are insufficient data with MACI use in pregnant women to inform a product-associated risk.

Animal reproduction studies have not been conducted with MACI. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of MACI in pediatric patients have not been established.

🧓 Geriatric Use 33 words ▾

8.5Geriatric Use The safety and effectiveness of MACI in patients over 65 years of age have not been established. Clinical trials of MACI did not include subjects over the age of 55.

🧬 Clinical Pharmacology 57 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action No clinical pharmacology studies have been conducted with MACI and a mechanism of action has not been established.

12.3Pharmacokinetics Clinical pharmacokinetic studies have not been performed with MACI. Studies in rabbits and horses indicated that the membrane is resorbed over a period of at least 6 months following implantation.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action No clinical pharmacology studies have been conducted with MACI and a mechanism of action has not been established.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied A single patient order may contain one (1) or two (2) implants, each in its own bottle and shipper, depending on lesion size and number of lesions. MACI - One (1) Implant MACI, NDC69866-1030-5 (outer box), contains one (1) implant supplied ready for use as a single cellular sheet approximately 3 x 5 cm, in a sterile, sealed, translucent perfluoroalkoxy (PFA) resin bottle and cap. Each bottle contains one 3 x 5 cm implant with a 0.5-cm 2 section removed from the lower left-hand corner.

MACI - Two (2) Implant MACI, NDC69866-1030-8 (outer box), contains two (2) implants supplied ready for use as cellular sheets approximately 3 x 5 cm, in a sterile, sealed, translucent perfluoroalkoxy (PFA) resin bottle and cap. Each bottle contains one 3 x 5 cm implant with a 0.5 cm 2 section removed from the lower left-hand corner. Each bottle is individually sealed in a clear self-seal pouch.

Each self-seal pouch is placed into a 95kPa outer bag with absorbent material. These bags are enclosed in an outer box insulated with ambient temperature gel packs. Storage and Handling Store MACI at room temperature in its original packaging (outer box) until ready to use.

DO NOT REFRIGERATE or FREEZE, or sterilize MACI. DO NOT USE if the bottle is damaged, has been compromised, or has leaked. Use MACI prior to 11:59 PM EST on the date of expiration printed on the package.

Dispose of unused MACI or waste material as surgical biohazardous waste in accordance with local requirements.

📋 Description ~1 min read ▾

11 DESCRIPTION MACI, autologous cultured chondrocytes on porcine collagen membrane, is a cellular sheet that consists of autologous chondrocytes seeded on a 3 x 5 cm, resorbable porcine Type I/III collagen membrane, for implantation into cartilage defects of the knee. The active ingredients of MACI are the autologous cultured chondrocytes and porcine Type I/III collagen. The autologous chondrocytes are propagated in cell culture and are seeded on the collagen at a density of 500,000 to 1,000,000 cells per cm 2 .

The final MACI implant contains at least 500,000 cells per cm 2 and does not contain any preservative. The product manufacture also uses reagents derived from animal materials. The resorbable, Type I/III, collagen membrane, which is a component of MACI, is porcine-derived.

Fetal bovine serum is a component in the culture medium used to propagate the autologous chondrocytes; therefore, trace quantities of bovine-derived proteins may be present in MACI. These animal-derived reagents are tested for viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma before use. MACI may contain residual gentamicin because it is included during manufacture.

Gentamicin is not included in the transport medium used to maintain product stability. Studies determined an average of 9.2 μg residual gentamicin per MACI implant. A final sterility test is initiated prior to shipping, but the result will not be available prior to implantation.

Passing results from preliminary in-process microbial tests are required for release of MACI for shipping.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient that: A cartilage biopsy is needed to manufacture MACI. The biopsy is typically performed as an arthroscopic procedure at the time of diagnosis confirmation. The length of time between the biopsy and the implantation of MACI may vary depending on many factors, including the quality and number of cells obtained from the biopsy.

Cells can be held in storage until a convenient date for surgery is agreed upon between the patient and the surgeon. Even if the surgeon has taken a biopsy needed to produce MACI, it may be possible that the patient cannot be treated with MACI, (e.g., in case the biopsy is of insufficient quality to produce MACI, if the cells cannot be grown in the laboratory, or if the expanded cells do not meet all the quality requirements). Advise the patient on the risk of graft complications, subsequent surgical procedures, and treatment failure. [See Adverse Reactions ( 6 )] Advise the patient on general complications related to knee surgery, which may include deep vein thrombosis and pulmonary embolism.

Advise the patient to closely follow the physician-prescribed rehabilitation program, which will include limitations and allowances for beginning specific physical activities. [See Dosage and Administration ( 2.3 )] Inform patient about the possible risk of transmission of infectious diseases with MACI implantation. [See Warnings and Precautions ( 5.2 )] Manufactured by: Vericel Corporation, 64 Sidney Street, Cambridge, MA 02139 MACI ® is a registered trademark of Vericel Corporation. Patents: www.vcel.com/research-and-development © 2025 Vericel Corporation.

65628 Revision 4 09/2025 Manufactured by: Vericel Corporation, 25 Blue Sky Drive, Burlington, MA 01803 MACI ® is a registered trademark of Vericel Corporation. Patents: www.vcel.com/research-and-development © 2026 Vericel Corporation. 65655 Revision 1 03/2026

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69864-0002-30 · The 69866-2002-03 · Vericel →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.