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510(k) K190439

Engage™ Partial Knee System by Engage Uni, LLC — Product Code NJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2019
Date Received
February 25, 2019
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 for product code NJD

  • K251975 — Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (September 2, 2025)
  • K242307 — ACHIEVE Partial Knee System (December 16, 2024)
  • K222653 — JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (October 28, 2022)
  • K133811 — RESTORIS POROUS PARTIAL KNEE SYSTEM (July 8, 2014)