FDA 510(k) Applications for Medical Device Product Code "KRR"
(Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)

FDA 510(k) Number Applicant Device Name Decision Date
K073120 ACCELERATED INNOVATION, LLC ACCIN PATELLOFEMORAL SYSTEM 02/29/2008
K160461 Arthrex, Inc. Arthrex iBalance BiCompartmental Arthroplasty System 04/12/2016
K060127 ARTHROSURFACE, INC. HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS 03/16/2006
K071413 ARTHROSURFACE, INC. HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM 11/09/2007
K181280 Arthrosurface, Inc. Patello-Femoral Wave (Kahuna) Arthroplasty System 06/14/2018
K143543 BIOMET INC. Prelude PF Patellae 01/30/2015
K123907 BIOMET MANUFACTURING CORP. PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, 09/03/2013
K001374 BIOMET MANUFACTURING, INC. PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT 07/27/2000
K001350 BIOMET, INC. PATIENT MATCHED TITANIUM ALLOY TROCHLEA 07/26/2000
K221048 Episurf Medical, Inc. Episealer Patellofemoral System 12/23/2022
K050473 GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. RBK PATELLA FEMORAL KNEE 11/14/2005
K051948 HOWMEDICA OSTEONICS CORP AVON PATELLO-FEMORAL JOINT PROSTHESIS 10/21/2005
K041160 HOWMEDICA OSTEONICS CORP. AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT 05/27/2004
K020841 HOWMEDICA OSTEONICS CORP. AVON PATELLAR COMPONENT 04/11/2002
K010100 HOWMEDICA OSTEONICS CORP. AVON PATELLO-FEMORAL JOINT PROSTHESIS 04/06/2001
K211303 Howmedica Osteonics Corp., dba Stryker Orthopaedics Avon Patello-femoral Joint Prosthesis 06/04/2021
K962190 INTERMEDICS ORTHOPEDICS PATELLOFEMORAL JOINT PROSTHESIS 10/28/1996
K013982 KINAMED, INC. KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT 05/21/2002
K080029 MAKO SURGICAL CORP. MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM 05/16/2008
K082088 MAKO SURGICAL CORP. MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II 10/22/2008
K200122 Medacta International SA MOTO PFJ System 04/20/2020
K231253 Overture Resurfacing Inc. Overture Orthopaedics Patellofemoral System 07/07/2023
K051086 SMITH & NEPHEW, INC. SMITH & NEPHEW PATELLO-FEMORAL IMPLANT 05/31/2005
K002356 SULZER ORTHOPEDICS, INC. NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS 10/30/2000
K111970 TORNIER KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT 02/23/2012
K000827 WALTER ABENDSCHEIN, M.D. UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED 06/23/2000
K070695 ZIMMER, INC. ZIMMER PATELLOFEMORAL JOINT PROSTHESIS 06/07/2007


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