QVV · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3610
Classification
FDA Product Code
QVV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3610
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.