21 CFR 888.3610 — Medial Knee Implanted Shock Absorber
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3610
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)
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QVV | Medial Knee Implanted Shock Absorber | 2 | 1 | Implant |
Special Controls
QVV — Medial Knee Implanted Shock Absorber
In combination with the general controls of the FD&C Act, the medial knee implanted shock absorber is subject to the following special controls:
De Novo Order DEN220033
