FDA 510(k) Applications for Medical Device Product Code "NPJ"
(Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)

FDA 510(k) Number Applicant Device Name Decision Date
K053488 CONFORMIS, INC. CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM 03/09/2006
K093513 CONFORMIS, INC. IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM 12/16/2009
K070849 DEPUY ORTHOPAEDICS, INC. DEPUY GCK FEMORAL AND TIBIAL COMPONENTS 06/26/2007
K061648 DEPUY ORTHOPAEDICS, INC. DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) 09/11/2006
K052917 HOWMEDICA OSTEONICS CORP STRYKER COMPARTMENTAL KNEE SYSTEM 12/27/2005
K150307 MAKO SURGICAL CORP. RESTORIS Multicompartmental Knee System 03/10/2015
K090763 MAKO SURGICAL CORPORATION RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM 06/17/2009
K133039 MAKO SURGICAL CORPORATION RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM 12/10/2013
K061569 SMITH & NEPHEW, INC. SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS 07/06/2006
K052265 SMITH & NEPHEW, INC. SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL 12/27/2005
K042896 SMITH & NEPHEW, INC. SMITH & NEPHEW HYBRID KNEE FEMORAL 01/12/2005
K093056 SMITH & NEPHEW, INC. SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM 12/15/2009


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