Medial Knee Implanted Shock Absorber
The Medial Knee Implanted Shock Absorber is a device implanted outside the knee capsule, extending from the distal femur to the proximal tibia, intended to reduce loads on the medial intra-articular joint surface through a shock-absorbing mechanical system stabilized by plates and screws, used to treat conditions such as medial compartment knee osteoarthritis. The device is not intended to span the lateral knee. Classified as FDA Class 2 under regulation 888.3610, it requires 510(k) clearance in the Orthopedic specialty and is flagged as an implant. It is not life-sustaining.
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Basic Information
- Product Code
- QVV
- Device Class
- FDA class 2
- Regulation Number
- 888.3610
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220033 | MISHA Knee System | Apr 10, 2023 | Unknown | Moximed, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.