Product code QVV— Orthopedic
MISHA Knee System
- Classification name
- Medial Knee Implanted Shock Absorber
- Device class
- Class 2
- Regulation
- 21 CFR 888.3610
- Advisory panel
- Orthopedic
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QVV
FDA has cleared device under product code QVV, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QVV
Recent clearances under product code QVV
Data sourced from openFDA. This site is unofficial and independent of the FDA.