Implant, Resorbable, For Articular Osteochondral Repair
The Resorbable Implant for Articular Osteochondral Repair is a surgically implanted device intended to repair cartilage or osteochondral lesions of the knee joint surface, providing structural support that gradually resorbs as the defect heals. Given the complexity and risk of articular cartilage repair in a load-bearing joint, the device is classified as FDA Class 3 requiring Premarket Approval (PMA), reviewed under the Orthopedic panel. It is flagged as an implant, as it is placed within the knee joint, and is not life-sustaining. No regulation number is assigned.
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Basic Information
- Product Code
- QRU
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
Definition
This device is intended to repair knee joint surface cartilage or osteochondral lesions.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.