FDA 510(k) Applications for Medical Device Product Code "KWZ"
(Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)

FDA 510(k) Number Applicant Device Name Decision Date
K021661 BIOMET ORTHOPEDICS, INC. RINGLOC CONSTRAINED LINERS 10/25/2002
K030047 BIOMET, INC. FREEDOM CONSTRAINED LINERS 01/23/2003
K021728 BIOMET, INC. RINGLOC CONSTRAINED LINERS II 10/25/2002
K030923 CENTERPULSE ORTHOPEDICS, INC. EPSILON DURASUL CONSTRAINED ACETABULAR LINER 10/03/2003
K240639 Depuy Ireland UC PINNACLETM Constrained Acetabular Liners 04/04/2024
K071059 DEPUY ORTHOPAEDICS, INC. DEPUY SPA POROUS COATED PROXIMAL SLEEVE 11/09/2007
K071117 DEPUY ORTHOPAEDICS, INC. MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS 05/18/2007
K052079 DEPUY ORTHOPAEDICS, INC. PINNACLE CONSTRAINED ACETABULAR LINERS 10/21/2005
K043058 DEPUY, INC. PINNACLE CONSTRAINED ACETABULAR LINERS 03/14/2005
K023794 ENCORE MEDICAL, L.P. CONSTRAINED LINER 04/01/2003
K161610 Encore Medical, L.P. EXPRT Revision Hip System 11/09/2016
K163497 ENCORE MEDICAL, L.P. EXPRTÖ Revision Hip System - EXPRTÖ Hip Distal Stem, EXPRTÖ Hip Standard Offset Proximal Body Implant, EXPRTÖ Hip Lateral Offset Proximal Body Implant, EXPRTÖ Hip Capture Bolt 03/02/2017
K040601 EXACTECH, INC. EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS 10/04/2004
K071676 EXACTECH, INC. EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS 07/19/2007
K063445 HOWMEDICA OSTEONICS CORP PCA CONSTRAINED ACETABULAR LINERS 03/08/2007
K063552 HOWMEDICA OSTEONICS CORP SERIES II CONSTRAINED ACETABULAR LINERS 03/08/2007
K063550 HOWMEDICA OSTEONICS CORP SYSTEM 12 CONSTRAINED ACETABULAR LINERS 03/08/2007
K061654 HOWMEDICA OSTEONICS CORP TRIDENT CONSTRAINED ACETABULAR INSERT 07/07/2006
K040225 OSTEOIMPLANT TECHNOLOGY, INC. OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM 05/06/2004
K083566 SMITH & NEPHEW, INC. R3 CONSTRAINED LINER, CONSTRAINED LINER 03/03/2009
K021803 SMITH & NEPHEW, INC. REFLECTION CONSTRAINED LINER 12/19/2002
K033442 SMITH & NEPHEW, INC. REFLECTION CONSTRAINED LINER 11/26/2003
K122139 SMITH & NEPHEW, INC. SMITH & NEPHEW R3 CONSTRAINED LINERS 10/16/2012
K111635 SMITH & NEPHEW, INC. SMITH & NEPHEW RJ CONSTRAINED LINERS 09/09/2011
K162641 Smith & Nephew, Inc. Smith & Nephew, Inc. R3Ö Constrained Liner 06/19/2017
K101730 ZIMMER, INC. LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS 12/03/2010
K072121 ZIMMER, INC. TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER 01/07/2008
K021826 ZIMMER, INC. TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES 12/20/2002
K071718 ZIMMER, INC. TRILOGY LONGEVITY CONSTRAINED LINER 07/13/2007


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