QVV — Medial Knee Implanted Shock Absorber Class II

FDA Device Classification

Classification Details

Product Code
QVV
Device Class
Class II
Regulation Number
888.3610
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN220033moximedMISHA Knee SystemApril 10, 2023