DEN220033 is an FDA 510(k) submission for the MISHA Knee System. This device is classified as a Medial Knee Implanted Shock Absorber (Class II - Special Controls, product code QVV).
Submitted by Moximed, Inc. (Fremont, US). The FDA issued a Not Cleared (DENG) decision on April 10, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 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..
| 510(k) Number | DEN220033 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 06, 2022 |
| Decision Date | April 10, 2023 |
| Days to Decision | 308 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QVV - Medial Knee Implanted Shock Absorber |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3610 |
| Definition | 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. |