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 |