Product code HRY

Device name: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Medical specialty: Orthopedic
Device class: 2
Regulation number: 888.3530
Review panel: OR
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P840049S001	P.C.A.(TM) TOTAL KNEE SYSTEM	Howmedica Corp.	1991-09-10
P840049	P.C.A.(TM) TOTAL KNEE SYSTEM	Howmedica Corp.	1988-09-30

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K193549	SIGMA High Performance (HP) Partial Knee System	Depuy Ireland UC	2020-04-16
K190633	NanoOrtho NanoKnee® System	Nanoortho, LLC	2019-12-20
K152631	MPO Total Knee Systems MR Labeling	Microport Orthopedics, Inc.	2016-03-23
K150410	RESTORIS POROUS PARTIAL KNEE SYSTEM	Mako Surgical Corporation	2015-03-20
K133940	OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)	Biomet UK, Ltd.	2014-03-28
K131167	UNIVATION	Aesculap Implant Systems, LLC	2013-10-17
K122277	OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM	Biomet Manufacturing Corp	2012-10-22
K110415	SIGNATURE PLANNER / SIGNATURE GUIDES	Materialise NV	2011-05-16
K100973	EVOLUTION UNICONDYLAR KNEE SYSTEM	Wrightmedicaltechnologyinc	2010-08-10
K082567	STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION	Howmedica Osteonics Corp.	2008-10-03
K081293	UNIVATION UNICONDYLAR KNEE SYSTEM	Aesculap Implant Systems, Inc.	2008-09-22
K072704	UNICOMPARTMENTAL KNEE	Valpo Orthopedic Technology, Inc.	2008-02-19
K071881	TRIATHLON PKR SYSTEM	Howmedica Osteonics Corp.	2007-10-09
K070267	DEPUY GCK TIBIAL COMPONENTS	DePuy Orthopaedics, Inc.	2007-08-17
K063515	TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE	Biomet Manufacturing, Inc.	2007-02-02
K061681	REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT	Biomet Manufacturing Corp	2006-10-19
K060412	ACTIVE UNICOMPARTMENTAL KNEE SYSTEM	Australian Surgical Design & Manufacture	2006-05-17
K053299	REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT	Biomet Manufacturing, Inc.	2006-01-05
K051721	GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM	Global Orthopaedic Technology, USA, Inc.	2005-10-26
K050764	UNIGLIDE UNICONDYLAR KNEE PROSTHESIS	Corin USA	2005-08-24
K042093	VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS	Biomet, Inc.	2004-11-01
K040889	EXACTECH OPTETRAK UNICONDYLAR KNEE	Exactech, Inc.	2004-10-01
K040268	DEPUY PRESERVATION UNICONDYLAR TIBIA	DePuy Orthopaedics, Inc.	2004-05-05
K033351	GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE	Global Orthopaedic Technology, USA, Inc.	2004-03-11
K033810	NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM	Centerpulse Orthopedics, Inc.	2004-03-05
K032052	UC-PLUS SOLUTION UNICONDYLAR KNEE	Plus Orthopedics	2003-07-25
K030446	REPICCI LOCKED KEEL TIBIAL BEARING	Biomet, Inc.	2003-03-06
K030193	ADVANCE LESS CONFORMING TIBIAL COMPONENT	Wrightmedicaltechnologyinc	2003-02-20
K022437	UNI KNEE	Encore Medical L.P.	2002-08-23
K021621	FIXED BEARING UNI COMPONENT	Biomet, Inc.	2002-06-05

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
07613154557431	INSTRUMENT	Howmedica Osteonics Corp.	2016-09-24
00848486016418	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016739	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016715	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016708	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016692	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016685	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016661	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016654	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016647	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016630	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016616	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016609	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016593	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016586	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016562	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016555	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016548	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016531	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016517	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016500	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016494	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016487	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016463	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016456	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016449	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016432	Mako	MAKO SURGICAL CORP.	2015-11-04
00848486016401	Mako	MAKO SURGICAL CORP.	2015-11-04
07613327014549	Scorpio	Howmedica Osteonics Corp.	2015-09-24
07613327014556	Scorpio	Howmedica Osteonics Corp.	2015-09-24

Product code HRY

Related PMA Records#

Related 510(k) Records#

Related GUDID Devices#