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# Vericel’s Maci Approved for Knee Cartilage Repair
- URL: https://www.fdaweb.com/vericels-maci-approved-for-knee-cartilage-repair/
- Published: 2016-12-13T12:00:00.000Z
- Updated: 2026-09-14T21:54:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137559

FDA has approved a Vericel PMA for Maci (autologous cultured chondrocytes on porcine collagen membrane) for repairing symptomatic, full-thickness knee cartilage defects in adult patients. An [agency release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533153.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says Maci is the first approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.

“Maci is composed of a patient’s own (autologous) cells that are expanded and placed onto a bio-resorbable (can be broken down by the body) porcine-derived collagen membrane that is implanted over the area where the defective or damaged tissue was removed,” FDA says. Administration should be performed by a surgeon specifically trained in the device’s use. Each Maci implant consists of a small cellular sheet containing 500,000 to 1,000,000 cells per square centimeter.

Approval was based on data from a two-year clinical trial designed to demonstrate reduced pain and improved function in comparison to microfracture, an alternative surgical procedure for cartilage repair. “Overall efficacy data support a long-term clinical benefit from the use of the Maci implant in patients with cartilage defects,” the agency said.