QVVClass IIImplant

Medial Knee Implanted Shock Absorber

Orthopedic · 21 CFR 888.3610

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. 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.

MDR events15All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances1All time

Recent MDR events

15 adverse event reports on file

Event type breakdown

Injury8

Malfunction7

Most-reported manufacturers

Moximed, Inc.14 Moximed, Inc1

Recalls

1 recall events for this product code

Moximed, Inc.
Open, ClassifiedDec 23, 2024
MISHA Knee System Implant Small, Left, REF: 2-1001.
Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
Z-0762-2025 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Moximed, Inc.Apr 10, 2023
DEN220033 · MISHA Knee System