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Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

FDA product code KRO · 79 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3510
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1979-04-04 – 2026-08-06
KRO 2024-04-01

EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse

Applicant Microport Orthopedics, Inc.

K number K240043

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