HRY · Class II · 21 CFR 888.3530

FDA Product Code HRY: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

Leading manufacturers include Howmedica Corp., Biomet, Inc. and Wrightmedicaltechnologyinc.

91
Total
91
Cleared
106d
Avg days
1976
Since

FDA 510(k) Cleared Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer Devices (Product Code HRY)

91 devices
1–24 of 91
Cleared Apr 16, 2020
SIGMA High Performance (HP) Partial Knee System
K193549
Depuy Ireland UC
Orthopedic · 118d
Cleared Dec 20, 2019
NanoOrtho NanoKnee® System
K190633
Nanoortho, LLC
Orthopedic · 283d
Cleared Mar 23, 2016
MPO Total Knee Systems MR Labeling
K152631
Microport Orthopedics, Inc.
Orthopedic · 190d
Cleared Mar 20, 2015
RESTORIS POROUS PARTIAL KNEE SYSTEM
K150410
Mako Surgical Corporation
Orthopedic · 30d
Cleared Mar 28, 2014
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
K133940
Biomet UK, Ltd.
Orthopedic · 95d
Cleared Oct 17, 2013
UNIVATION
K131167
Aesculap Implant Systems, LLC
Orthopedic · 176d
Cleared Oct 22, 2012
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
K122277
Biomet Manufacturing Corp
Orthopedic · 84d
Cleared May 16, 2011
SIGNATURE PLANNER / SIGNATURE GUIDES
K110415
Materialise NV
Orthopedic · 91d
Cleared Aug 10, 2010
EVOLUTION UNICONDYLAR KNEE SYSTEM
K100973
Wrightmedicaltechnologyinc
Orthopedic · 124d
Cleared Oct 03, 2008
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Sep 22, 2008
UNIVATION UNICONDYLAR KNEE SYSTEM
K081293
Aesculap Implant Systems, Inc.
Orthopedic · 138d
Cleared Oct 09, 2007
TRIATHLON PKR SYSTEM
K071881
Howmedica Osteonics Corp.
Orthopedic · 92d
Cleared Aug 17, 2007
DEPUY GCK TIBIAL COMPONENTS
K070267
DePuy Orthopaedics, Inc.
Orthopedic · 200d
Cleared Feb 02, 2007
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
K063515
Biomet Manufacturing, Inc.
Orthopedic · 73d
Cleared Oct 19, 2006
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
K061681
Biomet Manufacturing Corp
Orthopedic · 126d
Cleared May 17, 2006
ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
K060412
Australian Surgical Design & Manufacture
Orthopedic · 90d
Cleared Jan 05, 2006
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299
Biomet Manufacturing, Inc.
Orthopedic · 41d
Cleared Oct 26, 2005
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
K051721
Global Orthopaedic Technology, USA, Inc.
Orthopedic · 121d
Cleared Aug 24, 2005
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
K050764
Corin USA
Orthopedic · 153d
Cleared Nov 01, 2004
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 01, 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889
Exactech, Inc.
Orthopedic · 179d
Cleared May 05, 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jul 25, 2003
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052
Plus Orthopedics
Orthopedic · 23d
Cleared Mar 06, 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446
Biomet, Inc.
Orthopedic · 23d

About Product Code HRY - Regulatory Context