510(k) DEN220033
DEN220033 is an FDA 510(k) premarket notification submitted by Moximed, Inc. for the device "MISHA Knee System". The FDA issued a decision of De Novo Granted on April 10, 2023. The device falls under product code QVV (Medial Knee Implanted Shock Absorber), a Class II device regulated under 21 CFR 888.3610.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 10, 2023
- Date Received
- June 6, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medial Knee Implanted Shock Absorber
- Device Class
- Class II
- Regulation Number
- 888.3610
- Review Panel
- OR
- Submission Type
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.