ClearanceBrief
Panels › Orthopedic › Product code HRY · Class 2

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Regulation 888.3530

0510(k)s in 12 months (91 all time)
0recalls in 12 months (68 all time)
68recalls that name a 510(k)
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Top companies in HRY

Company510(k)sRecalls
Biomet, Inc.1035
DePuy Orthopaedics, Inc.511
Howmedica Corp.110
Aesculap Implant Systems, Inc.28
Depuy, Inc.60
Wrightmedicaltechnologyinc60
Biomet Manufacturing Corp40
Microport Orthopedics, Inc.13
Osteonics Corp.40
Plus Orthopedics22
Decided510(k)Device and applicantCode
Apr 16, 2020K193549SIGMA High Performance (HP) Partial Knee System
Depuy Ireland UC, IE
HRY
Dec 20, 2019K190633NanoOrtho NanoKnee® System
Nanoortho, LLC
HRY
Mar 23, 2016K152631MPO Total Knee Systems MR Labeling
Microport Orthopedics, Inc.
HRY
Mar 20, 2015K150410RESTORIS POROUS PARTIAL KNEE SYSTEM
Mako Surgical Corporation
HRY
Mar 28, 2014K133940OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
Biomet UK, Ltd.
HRY
Oct 17, 2013K131167UNIVATION
Aesculap Implant Systems, LLC
HRY
Oct 22, 2012K122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
Biomet Manufacturing Corp
HRY
May 16, 2011K110415SIGNATURE PLANNER / SIGNATURE GUIDES
Materialise NV, BE
HRY
Aug 10, 2010K100973EVOLUTION UNICONDYLAR KNEE SYSTEM
Wrightmedicaltechnologyinc
HRY
Oct 3, 2008K082567STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
Howmedica Osteonics Corp.
HRY
Sep 22, 2008K081293UNIVATION UNICONDYLAR KNEE SYSTEM
Aesculap Implant Systems, Inc.
HRY
Feb 19, 2008K072704UNICOMPARTMENTAL KNEE
Valpo Orthopedic Technology, Inc.
HRY
Oct 9, 2007K071881TRIATHLON PKR SYSTEM
Howmedica Osteonics Corp.
HRY
Aug 17, 2007K070267DEPUY GCK TIBIAL COMPONENTS
DePuy Orthopaedics, Inc.
HRY
Feb 2, 2007K063515TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
Biomet Manufacturing, Inc.
HRY
Oct 19, 2006K061681REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
Biomet Manufacturing Corp
HRY
May 17, 2006K060412ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
Australian Surgical Design & Manufacture
HRY
Jan 5, 2006K053299REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
Biomet Manufacturing, Inc.
HRY
Oct 26, 2005K051721GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
Global Orthopaedic Technology, USA, Inc.
HRY
Aug 24, 2005K050764UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
Corin USA
HRY
Nov 1, 2004K042093VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
Biomet, Inc.
HRY
Oct 1, 2004K040889EXACTECH OPTETRAK UNICONDYLAR KNEE
Exactech, Inc.
HRY
May 5, 2004K040268DEPUY PRESERVATION UNICONDYLAR TIBIA
DePuy Orthopaedics, Inc.
HRY
Mar 11, 2004K033351GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
Global Orthopaedic Technology, USA, Inc.
HRY
Mar 5, 2004K033810NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
Centerpulse Orthopedics, Inc.
HRY
Jul 25, 2003K032052UC-PLUS SOLUTION UNICONDYLAR KNEE
Plus Orthopedics
HRY
Mar 6, 2003K030446REPICCI LOCKED KEEL TIBIAL BEARING
Biomet, Inc.
HRY
Feb 20, 2003K030193ADVANCE LESS CONFORMING TIBIAL COMPONENT
Wrightmedicaltechnologyinc
HRY
Aug 23, 2002K022437UNI KNEE
Encore Medical L.P.
HRY
Jun 5, 2002K021621FIXED BEARING UNI COMPONENT
Biomet, Inc.
HRY
Jun 4, 2002K020741UNICONDYLAR KNEE
Encore Orthopedics, Inc.
HRY
May 3, 2002K012800SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
Whiteside Biomechanics, Inc.
HRY
Mar 15, 2002K014171ADVANCE UNICONDYLAR KNEE SYSTEM
Wrightmedicaltechnologyinc
HRY
Feb 8, 2002K020264REPICCI II UNICONDYLAR KNEE SYSTEM
Biomet Orthopedics, Inc.
HRY
Dec 11, 2001K012762MJS POSTERIOR STABILIZED KNEE SYSTEM
Osteoimplant Technology, Inc.
HRY
Nov 2, 2001K012591ADVANCE UNICONDYLAR KNEE SYSTEM
Wrightmedicaltechnologyinc
HRY
Jul 10, 2001K011138OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
Biomet, Inc.
HRY
Jun 13, 2001K011795WORLAND UNICONDYLAR TIBIAL BEARING
Biomet, Inc.
HRY
Jun 13, 2001K011509BARRETT UNICONDYLAR TIBIAL BEARING
Biomet, Inc.
HRY
Apr 18, 2001K010810DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
DePuy Orthopaedics, Inc.
HRY
May 18, 2000K001451MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
DePuy Orthopaedics, Inc.
HRY
Apr 6, 2000K983657OSTEONICS SERIES 7000 AD TIBIAL TRAY
Osteonics Corp.
HRY
Feb 3, 2000K000172DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
DePuy Orthopaedics, Inc.
HRY
Jul 30, 1999K982859UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
Plus Orthopedics
HRY
May 20, 1998K980665REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
Biomet, Inc.
HRY
Jan 12, 1998K974434OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
Osteonics Corp.
HRY
Aug 25, 1997K971938REPICCI II UNICONDYLAR KNEE
Biomet, Inc.
HRY
Oct 10, 1996K954481P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
Johnson & Johnson Professionals, Inc.
HRY
Jul 25, 1996K961900TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
Wrightmedicaltechnologyinc
HRY
May 8, 1996K960617ADVANCE TIBIAL COMPONENT
Wrightmedicaltechnologyinc
HRY

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