Agili-C

FDA premarket approval P210034 · Implant, resorbable, for articular osteochondral repair

PMA numberP210034

Approval

Applicant
Smith and Nephew, Inc.
Received
September 30, 2021
Decision date
March 29, 2022 (APPR)
Supplements
1, latest June 4, 2026
Product code
QRU – Implant, Resorbable, For Articular Osteochondral Repair

Official FDA PMA record

Approval order statement

Approval for Agili-C. The Agili-C scaffold is indicated for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).