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Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

FDA product code QNI · 2 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3044
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-03-06 – 2026-01-13

A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.

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