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

FDA 510(k) Number Applicant Device Name Decision Date
K081293 AESCULAP IMPLANT SYSTEMS, INC. UNIVATION UNICONDYLAR KNEE SYSTEM 09/22/2008
K131167 AESCULAP IMPLANT SYSTEMS, LLC UNIVATION 10/17/2013
K060412 AUSTRALIAN SURGICAL DESIGN & MANUFACTURE ACTIVE UNICOMPARTMENTAL KNEE SYSTEM 05/17/2006
K122277 BIOMET MANUFACTURING CORP. OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM 10/22/2012
K061681 BIOMET MANUFACTURING CORP. REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT 10/19/2006
K053299 BIOMET MANUFACTURING, INC. REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT 01/05/2006
K063515 BIOMET MANUFACTURING, INC. TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE 02/02/2007
K020264 BIOMET ORTHOPEDICS, INC. REPICCI II UNICONDYLAR KNEE SYSTEM 02/08/2002
K133940 BIOMET UK LTD. OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) 03/28/2014
K011509 BIOMET, INC. BARRETT UNICONDYLAR TIBIAL BEARING 06/13/2001
K021621 BIOMET, INC. FIXED BEARING UNI COMPONENT 06/05/2002
K011138 BIOMET, INC. OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT 07/10/2001
K971938 BIOMET, INC. REPICCI II UNICONDYLAR KNEE 08/25/1997
K980665 BIOMET, INC. REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS 05/20/1998
K030446 BIOMET, INC. REPICCI LOCKED KEEL TIBIAL BEARING 03/06/2003
K042093 BIOMET, INC. VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS 11/01/2004
K011795 BIOMET, INC. WORLAND UNICONDYLAR TIBIAL BEARING 06/13/2001
K033810 CENTERPULSE ORTHOPEDICS, INC. NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM 03/05/2004
K050764 CORIN U.S.A. UNIGLIDE UNICONDYLAR KNEE PROSTHESIS 08/24/2005
K193549 DePuy Ireland UC SIGMA High Performance (HP) Partial Knee System 04/16/2020
K000172 DEPUY ORTHOPAEDICS, INC. DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS 02/03/2000
K070267 DEPUY ORTHOPAEDICS, INC. DEPUY GCK TIBIAL COMPONENTS 08/17/2007
K010810 DEPUY ORTHOPAEDICS, INC. DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS 04/18/2001
K040268 DEPUY ORTHOPAEDICS, INC. DEPUY PRESERVATION UNICONDYLAR TIBIA 05/05/2004
K001451 DEPUY ORTHOPAEDICS, INC. MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS 05/18/2000
K022437 ENCORE MEDICAL, L.P. UNI KNEE 08/23/2002
K020741 ENCORE ORTHOPEDICS, INC. UNICONDYLAR KNEE 06/04/2002
K040889 EXACTECH, INC. EXACTECH OPTETRAK UNICONDYLAR KNEE 10/01/2004
K033351 GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE 03/11/2004
K051721 GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM 10/26/2005
K082567 HOWMEDICA OSTEONICS CORP STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION 10/03/2008
K071881 HOWMEDICA OSTEONICS CORP TRIATHLON PKR SYSTEM 10/09/2007
K955778 INTERMEDICS ORTHOPEDICS NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM 03/08/1996
K954481 JOHNSON & JOHNSON PROFESSIONALS, INC. P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM 10/10/1996
K150410 MAKO SURGICAL CORPORATION RESTORIS POROUS PARTIAL KNEE SYSTEM 03/20/2015
K110415 MATERIALISE N.V. SIGNATURE PLANNER / SIGNATURE GUIDES 05/16/2011
K152631 MICROPORT ORTHOPEDICS, INC. MPO Total Knee Systems MR Labeling 03/23/2016
K190633 NanoOrtho, LLC NanoOrtho NanoKnee« System 12/20/2019
K012762 OSTEOIMPLANT TECHNOLOGY, INC. MJS POSTERIOR STABILIZED KNEE SYSTEM 12/11/2001
K983657 OSTEONICS CORP. OSTEONICS SERIES 7000 AD TIBIAL TRAY 04/06/2000
K974434 OSTEONICS CORP. OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS 01/12/1998
K032052 PLUS ORTHOPEDICS UC-PLUS SOLUTION UNICONDYLAR KNEE 07/25/2003
K982859 PLUS ORTHOPEDICS UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM 07/30/1999
K072704 VALPO ORTHOPEDIC TECHNOLOGY, INC. UNICOMPARTMENTAL KNEE 02/19/2008
K012800 WHITESIDE BIOMECHANICS, INC. SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM 05/03/2002
K030193 WRIGHT MEDICAL TECHNOLOGY, INC. ADVANCE LESS CONFORMING TIBIAL COMPONENT 02/20/2003
K960617 WRIGHT MEDICAL TECHNOLOGY, INC. ADVANCE TIBIAL COMPONENT 05/08/1996
K012591 WRIGHT MEDICAL TECHNOLOGY, INC. ADVANCE UNICONDYLAR KNEE SYSTEM 11/02/2001
K014171 WRIGHT MEDICAL TECHNOLOGY, INC. ADVANCE UNICONDYLAR KNEE SYSTEM 03/15/2002
K100973 WRIGHT MEDICAL TECHNOLOGY, INC. EVOLUTION UNICONDYLAR KNEE SYSTEM 08/10/2010
K961900 WRIGHT MEDICAL TECHNOLOGY, INC. TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM 07/25/1996


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