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510(k) K002356

NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS by Sulzer Orthopedics, Inc. — Product Code KRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2000
Date Received
August 2, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3540
Review Panel
OR
Submission Type

Other clearances by Sulzer Orthopedics, Inc.

  • K022985 — ASCENDENT ACETABULAR SYSTEM (December 5, 2002)
  • K021578 — NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE (August 9, 2002)
  • K020713 — MS-30 LATERAL FEMORAL STEM (May 14, 2002)
  • K013935 — ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS (December 13, 2001)
  • K013031 — MOST OPTIONS SYSTEM (December 7, 2001)
  • K012739 — CONVERGE ACETABULAR SYSTEM (November 14, 2001)
  • K012961 — SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM (October 18, 2001)
  • K011954 — SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE (September 19, 2001)
  • K010839 — CLS VARUS STEM/CLS 135 STEM (April 18, 2001)
  • K003758 — ALLOFIT ACETABULAR SYSTEM (March 7, 2001)

Other clearances for product code KRR

  • K231253 — Overture Orthopaedics Patellofemoral System (July 7, 2023)
  • K221048 — Episealer Patellofemoral System (December 23, 2022)
  • K211303 — Avon Patello-femoral Joint Prosthesis (June 4, 2021)
  • K200122 — MOTO PFJ System (April 20, 2020)
  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • K160461 — Arthrex iBalance BiCompartmental Arthroplasty System (April 12, 2016)
  • K143543 — Prelude PF Patellae (January 30, 2015)
  • K123907 — PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST (September 3, 2013)
  • K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (February 23, 2012)
  • K082088 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (October 22, 2008)