510(k) K061648

DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) by DePuy Orthopaedics, Inc. — Product Code NPJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 11, 2006
Date Received: June 13, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class: Class II
Regulation Number: 888.3560
Review Panel: OR
Submission Type

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

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K203167 — DePuy Corail AMT Hip Prosthesis (November 19, 2020)
K202472 — ACTIS Duofix Hip Prosthesis (October 21, 2020)
K201347 — DePuy ATTUNE Total Knee System (June 18, 2020)
K193540 — TRUMATCH Personalized Solutions (June 16, 2020)
K193398 — Summit DuoFix HA Coating (February 4, 2020)
K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis (November 26, 2019)
K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)

Other clearances for product code NPJ

K150307 — RESTORIS Multicompartmental Knee System (March 10, 2015)
K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (December 10, 2013)
K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (December 16, 2009)
K093056 — SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (December 15, 2009)
K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (June 17, 2009)
K070849 — DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (June 26, 2007)
K061569 — SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (July 6, 2006)
K053488 — CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (March 9, 2006)
K052917 — STRYKER COMPARTMENTAL KNEE SYSTEM (December 27, 2005)
K052265 — SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (December 27, 2005)