K240043
- 510(k) number
- K240043
- Device name
- 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. TN · US
- Product code
- KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemente
- Decision date
- 2024-04-01
- Date received
- 2024-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240043.pdf
Official FDA record: K240043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.