QVV · Class II · 21 CFR 888.3610

FDA Product Code QVV: Medial Knee Implanted Shock Absorber

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.

Leading manufacturers include Moximed, Inc..

1
Total
0
Cleared
308d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Medial Knee Implanted Shock Absorber Devices (Product Code QVV)

1 devices
1–1 of 1
Not Cleared Apr 10, 2023
MISHA Knee System
DEN220033
Moximed, Inc.
Orthopedic · 308d

About Product Code QVV - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QVV since 2023, with 0 receiving FDA clearance (average review time: 308 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QVV devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →