QVV · Medial Knee Implanted Shock Absorber
Orthopedic · 21 CFR 888.3610 · Class 2
Overview
| Product Code | QVV |
|---|---|
| Device Name | Medial Knee Implanted Shock Absorber |
| Regulation | 21 CFR 888.3610 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface to improve symptoms of osteoarthritis. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee.
Classification Rationale
Class II (special controls)
Special Controls
In combination with the general controls of the FD&C Act, the medial knee implanted shock absorber is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220033 | MISHA Knee System | Moximed, Inc. | Apr 10, 2023 | DENG |
Top Applicants
- Moximed, Inc. — 1 clearance
