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510(k) K251975

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component by Ignite Orthomotion — Product Code NJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2025
Date Received
June 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Device Class
Class II
Regulation Number
888.3535
Review Panel
OR
Submission Type

Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.

Other clearances by Ignite Orthomotion

  • K242307 — ACHIEVE Partial Knee System (December 16, 2024)

Other clearances for product code NJD

  • K242307 — ACHIEVE Partial Knee System (December 16, 2024)
  • K222653 — JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (October 28, 2022)
  • K190439 — Engage™ Partial Knee System (November 21, 2019)
  • K133811 — RESTORIS POROUS PARTIAL KNEE SYSTEM (July 8, 2014)