Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3610](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3610) → QVV — Medial Knee Implanted Shock Absorber

# QVV · Medial Knee Implanted Shock Absorber

_Orthopedic · 21 CFR 888.3610 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QVV

## Overview

- **Product Code:** QVV
- **Device Name:** Medial Knee Implanted Shock Absorber
- **Regulation:** [21 CFR 888.3610](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3610)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QVV/DEN220033.md) | MISHA Knee System | Moximed, Inc. | Apr 10, 2023 | DENG |

## Top Applicants

- Moximed, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QVV](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QVV)

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