Atlas FDA

HRY

91 FDA 510(k) clearances · Product code

84 daysmedian time to decision
255 days90th percentile
91clearances measured

FDA profile

Official device name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3530
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 1,218 · 2022: 840 · 2023: 396 · 2024: 430 · 2025: 301 · 2026: 193
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SIGMA High Performance (HP) Partial Knee System (K193549)Depuy Ireland UC2020-04-16
NanoOrtho NanoKnee® System (K190633)Nanoortho, LLC2019-12-20
MPO Total Knee Systems MR Labeling (K152631)Microport Orthopedics, Inc.2016-03-23
RESTORIS POROUS PARTIAL KNEE SYSTEM (K150410)Mako Surgical Corporation2015-03-20
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (K133940)Biomet UK, Ltd.2014-03-28
UNIVATION (K131167)Aesculap Implant Systems, LLC2013-10-17
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM (K122277)Biomet Manufacturing Corp2012-10-22
SIGNATURE PLANNER / SIGNATURE GUIDES (K110415)Materialise NV2011-05-16
EVOLUTION UNICONDYLAR KNEE SYSTEM (K100973)Wrightmedicaltechnologyinc2010-08-10
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (K082567)Howmedica Osteonics Corp.2008-10-03
UNIVATION UNICONDYLAR KNEE SYSTEM (K081293)Aesculap Implant Systems, Inc.2008-09-22
UNICOMPARTMENTAL KNEE (K072704)Valpo Orthopedic Technology, Inc.2008-02-19
TRIATHLON PKR SYSTEM (K071881)Howmedica Osteonics Corp.2007-10-09
DEPUY GCK TIBIAL COMPONENTS (K070267)DePuy Orthopaedics, Inc.2007-08-17
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE (K063515)Biomet Manufacturing, Inc.2007-02-02
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT (K061681)Biomet Manufacturing Corp2006-10-19
ACTIVE UNICOMPARTMENTAL KNEE SYSTEM (K060412)Australian Surgical Design & Manufacture2006-05-17
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT (K053299)Biomet Manufacturing, Inc.2006-01-05
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM (K051721)Global Orthopaedic Technology, USA, Inc.2005-10-26
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS (K050764)Corin USA2005-08-24
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS (K042093)Biomet, Inc.2004-11-01
EXACTECH OPTETRAK UNICONDYLAR KNEE (K040889)Exactech, Inc.2004-10-01
DEPUY PRESERVATION UNICONDYLAR TIBIA (K040268)DePuy Orthopaedics, Inc.2004-05-05
GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE (K033351)Global Orthopaedic Technology, USA, Inc.2004-03-11
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM (K033810)Centerpulse Orthopedics, Inc.2004-03-05
UC-PLUS SOLUTION UNICONDYLAR KNEE (K032052)Plus Orthopedics2003-07-25
REPICCI LOCKED KEEL TIBIAL BEARING (K030446)Biomet, Inc.2003-03-06
ADVANCE LESS CONFORMING TIBIAL COMPONENT (K030193)Wrightmedicaltechnologyinc2003-02-20
UNI KNEE (K022437)Encore Medical L.P.2002-08-23
FIXED BEARING UNI COMPONENT (K021621)Biomet, Inc.2002-06-05
UNICONDYLAR KNEE (K020741)Encore Orthopedics, Inc.2002-06-04
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM (K012800)Whiteside Biomechanics, Inc.2002-05-03
ADVANCE UNICONDYLAR KNEE SYSTEM (K014171)Wrightmedicaltechnologyinc2002-03-15
REPICCI II UNICONDYLAR KNEE SYSTEM (K020264)Biomet Orthopedics, Inc.2002-02-08
MJS POSTERIOR STABILIZED KNEE SYSTEM (K012762)Osteoimplant Technology, Inc.2001-12-11
ADVANCE UNICONDYLAR KNEE SYSTEM (K012591)Wrightmedicaltechnologyinc2001-11-02
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT (K011138)Biomet, Inc.2001-07-10
WORLAND UNICONDYLAR TIBIAL BEARING (K011795)Biomet, Inc.2001-06-13
BARRETT UNICONDYLAR TIBIAL BEARING (K011509)Biomet, Inc.2001-06-13
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS (K010810)DePuy Orthopaedics, Inc.2001-04-18
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS (K001451)DePuy Orthopaedics, Inc.2000-05-18
OSTEONICS SERIES 7000 AD TIBIAL TRAY (K983657)Osteonics Corp.2000-04-06
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS (K000172)DePuy Orthopaedics, Inc.2000-02-03
UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM (K982859)Plus Orthopedics1999-07-30
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS (K980665)Biomet, Inc.1998-05-20
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS (K974434)Osteonics Corp.1998-01-12
REPICCI II UNICONDYLAR KNEE (K971938)Biomet, Inc.1997-08-25
P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM (K954481)Johnson & Johnson Professionals, Inc.1996-10-10
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM (K961900)Wrightmedicaltechnologyinc1996-07-25
ADVANCE TIBIAL COMPONENT (K960617)Wrightmedicaltechnologyinc1996-05-08
NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM (K955778)Intermedics Orthopedics1996-03-08
GAS PLASMA STERILIZATION (K944538)Depuy, Inc.1995-09-26
S.T.E.P. UNI-KNEE (K940389)S.T.E.P. Orthopaedics, Inc.1995-01-19
CKS POROUS COATED FEMORAL COMPONENT (K933935)Techmedica, Inc.1994-10-11
OSTEONICS UNIX UNICOMPARTMENTAL (K923011)Osteonics Corp.1993-11-30
P.F.C. UNICONDYLAR KNEE SYSTEM (K910968)Johnson & Johnson Orthopaedics, Inc.1991-08-26
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP (K911373)Osteonics Corp.1991-06-26
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION (K902538)Dow Corning Wright1990-07-06
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE (K890044)Biopro, Inc.1989-11-06
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM (K883969)Intermedics Orthopedics1989-04-19
KINEMAX TIBIAL WEDGE (K884837)Howmedica Corp.1989-02-17
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM (K882241)Kirschner Medical Corp.1988-06-29
AGC UNICOMPARTMENTAL KNEE PROSTHESIS (K873601)Biomet, Inc.1988-01-20
WHITESIDE ORTHOLOC (TM) (K864070)Dow Corning Wright1987-01-27
ARIZONA CONDYLAR TIBIAL PLATEAU (K862125)Depuy, Inc.1986-06-27
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU (K860133)Depuy, Inc.1986-03-10
HOWMEDICA KINEMATIC II TIBIAL WEDGE (K842367)Howmedica Corp.1984-08-17
UNICONDYLAR FIBER METAL KNEE (K834298)Zimmer, Inc.1984-02-13
P.C.A. UNICOMPARTMENTAL KNEE PROSTHES (K831143)Howmedica Corp.1983-08-16
IOI METAL BACKED TIBIAL COMPONENT (K821341)Intermedics Orthopedics1982-06-03
BARD CONTOUR LINK S.K.I. KNEE SYS (K820002)C.R. Bard, Inc.1982-05-27
HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE (K820030)Howmedica Corp.1982-02-05
TOWNLEY UNICONDYLAR KNEE (K812012)Depuy, Inc.1981-09-24
P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH (K810060)Howmedica Corp.1981-04-07
KNEE PROSTHESIS (K810540)Cintor Orthopaedic Div.1981-04-07
MILLER MULTI-RADIUS TOTAL KNEE (K810616)Zimmer, Inc.1981-03-20
CONDYLAR KNEE W/METAL ENCAPSULATED TIB (K810230)Hexcel Medical1981-03-06
RANAWAT ESF TOTAL CONDYLAR KNEE (K802446)Howmedica Corp.1980-10-31
RMC KNEE METAL SHOE TIBIAL COMPONENTS (K792619)Richard'S Medical Equip., Inc.1980-02-05
LIVERPOOL KNEE PROSTHESIS (K792325)Downs Surgical , Ltd.1980-01-21
PLATFORM TCCK TOTAL KNEE (K790762)Biomet, Inc.1979-05-14
ANAMETRIC TIBIAL COMPONENT METAL TRAY (K790348)Howmedica Corp.1979-03-06
TOTAL CONDYLAR KNEE PROSTHESIS (K790349)Howmedica Corp.1979-03-06
POSTERIOR CRUCIATE CONDYLAR TIBIAL (K790350)Howmedica Corp.1979-03-06
CENTRAL PEG TIBIAL COMPONENT (K781608)Howmedica Corp.1978-09-27
TOTAL KNEE SYSTEM (K780299)Richard'S Medical Equip., Inc.1978-04-27
TOTAL TIBIAL KNEE (K761278)Depuy, Inc.1977-01-05
GEOMEDIC ANAMETRIC TOTAL KNEE (K760842)Howmedica Corp.1976-10-20
TAVERNETTI-TENNANT (K760744)Cutter Laboratories, Inc.1976-10-07
PROSTEHSIS, TOTAL KNEE REPLACEMENT (K760334)Depuy, Inc.1976-08-11
PROSTHESIS, RICHARDS MOD II KNEE (K760245)Richard'S Medical Equip., Inc.1976-07-26

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Every clearance here is in the API, with alerts when new ones post.