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510(k) K061648

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

K061648 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)". The FDA issued a decision of Substantially Equivalent on September 11, 2006. The device falls under product code NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by DePuy Orthopaedics, Inc.

  • K252887 — DePuy ATTUNE™ Knee System (May 22, 2026)
  • K231503 — CUPTIMIZE™ Advanced (August 22, 2023)
  • K213839 — DePuy Corail AMT Hip Prosthesis (January 6, 2022)
  • K210167 — DELTA XTEND Reverse Shoulder System (February 19, 2021)
  • 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)

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)

FDA data resources