Atlas FDA

KWY

99 FDA 510(k) clearances · Product code

90 daysmedian time to decision
328 days90th percentile
99clearances measured

FDA profile

Official device name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3390
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 276 · 2022: 208 · 2023: 178 · 2024: 209 · 2025: 182 · 2026: 138
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
b-ONE® Bipolar Head (K253357)B-One Ortho, Corp.2026-04-13
Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634)Maxx Orthopedics, Inc.2025-08-25
CORAIL Cemented Femoral Stem (K231526)Depuy Ireland UC2023-12-19
SpaceFlex Acetabular Cup (K223441)G21, S.R.L.2023-03-23
Vario-Cup System (K221794)Waldemar Link GmbH & Co. KG2022-07-20
COPAL exchange G hip spacer (K220492)Heraeus Medical GmbH2022-03-23
Kyocera Bipolar Hip System (K200709)Kyocera Medical Technologies, Inc.2020-04-17
Fitmore Hip Stem (K192236)Zimmer GmbH2019-11-05
COPAL exchange G Hip and Knee Spacers (K191016)Heraeus Medical GmbH2019-11-01
iNSitu Bipolar Hip System (K191297)Theken Companies, LLC2019-09-17
Implantcast ic-Bipolar Head System (K191569)Implantcast GmbH2019-08-28
Corin BiPolar-i (K183114)Corin U.S.A. Limited2019-06-05
SurgTech Bipolar Head System (K173455)Surgtech, Inc.2018-06-14
ELEOS™ Bipolar Acetabular System (K180130)Onkos Surgical, Inc.2018-02-23
40-42mm BiPolar Head and 22mm Femoral Head (K163081)Signature Orthopaedics Pty, Ltd.2018-01-29
Fitmore® Hip Stem (K170072)Zimmer GmbH2017-02-07
U2 Bipolar Implant and 22mm Femoral Head (K152439)United Orthopedic Corporation2016-04-07
Klassic BiPolar System (K143113)Total Joint Orthopedics2015-01-28
RING-LOK MODULAR BIPOLAR SYSTEM (K132539)Implants International, Ltd.2014-02-07
RENOVIS BIPOLAR HIP SYSTEM (K131354)Renovis Surgical Technologies, LLC2013-09-19
DEPUY CORAIL AMT HIP PROSTHESIS (K123991)Depuy France S.A.S.2013-09-16
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT (K121509)Tgm Medical, Inc.2012-11-05
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP (K112019)Corentec Co., Ltd.2011-10-12
BIOPRO POLAR HEAD (K100761)Biopro, Inc.2010-12-03
UNITED U2 BIPOLAR IMPLANT (K101670)United Orthopedic Corp.2010-10-08
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) (K100151)Omnlife Science2010-05-28
MEDACTA BIPOLAR HEAD (K091967)Medacta International S.A.2010-03-02
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) (K082468)Omni Life Science, Inc.2009-02-18
BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (K082705)Biopro, Inc.2008-12-15
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT (K080979)Biomet Manufacturing Corp2008-10-31
ACCIN BIPOLAR HEAD SYSTEM (K080647)Accelerated Innovation, LLC2008-07-08
GLADIATOR BIPOLAR SYSTEM (K062693)Wrightmedicaltechnologyinc2006-09-29
AESCULAP BIPOLAR ACETABULAR CUP (K060707)Aesculap, Inc.2006-05-31
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM (K052990)Biomet, Inc.2005-12-16
U1 HIP SYSTEM - BIPOLAR (K050269)United Orthopedic Corp.2005-08-29
PIVOT BIPOLAR FEMORAL HEAD (K050966)Ortho Development Corp.2005-07-07
DURASUL BIPOLAR (K040947)Centerpulse Orthopedics, Inc.2004-08-27
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM (K023743)Smith & Nephew, Inc.2003-01-23
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) (K014072)Disc-O-Tech Medical Technologies, Ltd.2002-03-08
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS (K013211)Exactech, Inc.2001-12-05
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS (K010081)Exactech, Inc.2001-02-05
M2A 32MM TAPER SYSTEM (K003363)Biomet, Inc.2000-12-15
TRI-POLAR SYSTEM (K991990)Biomet, Inc.1999-09-10
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) (K982812)Johnson & Johnson Professionals, Inc.1998-12-04
PLUS BIPOLAR PROSTHESIS COCRMO (K982447)Plus Orthopedics1998-11-25
ODC B2 BIPOLAR CUP (K982389)Ortho Development Corp.1998-10-07
BIPOLAR FEMORAL HEAD (K981238)Whiteside Biomechanics, Inc.1998-08-21
J-FX BIPOLAR HEAD (K980801)Johnson & Johnson Professionals, Inc.1998-05-29
IMPLEX BIPOLAR HIP SYSTEM (K970447)Implex Corp.1997-04-30
ARTOS, DIPLOS SYSTEM (K970284)Turnkey Intergration USA, Inc.1997-04-21
ADVANTAGE MAPF HIP FEMORAL COMPONENT (K960643)Biomet, Inc.1996-12-16
ULTIMA FX FEMORAL HIP STEMS (K963885)Johnson & Johnson Professionals, Inc.1996-12-09
PRIMALOC CEMENTED HIP SYSTEM (K962448)Ortho Development Corp.1996-09-19
BI-LOC BIPOLAR CUP (K961793)Ortho Development Corp.1996-07-26
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT (K945518)Johnson & Johnson Professionals, Inc.1996-03-08
PRIMALOC CEMENTLESS HIP SYSTEM (K953977)Ortho Development Corp.1996-01-26
UHMWPE COMPONENTS-CHANGE IN PACKAGING (K940743)Depuy, Inc.1995-09-18
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS (K953510)Encore Orthopedics, Inc.1995-08-09
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR (K945793)Johnson & Johnson Professionals, Inc.1995-04-10
MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (K941534)3M Health Care, Ltd.1995-03-06
P.F.C. TOTAL HIP SYSTEM (K944132)Johnson & Johnson Professionals, Inc.1995-01-06
IOI COCR UNIPOLAR PROSTHESIS (K934159)Intermedics Orthopedics1994-07-21
P.F.C. BIPOLAR HIP SYSTEM (K931655)Johnson & Johnson Orthopaedics, Inc.1994-06-09
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM (K925153)Howmedica Corp.1994-03-01
TECHMEDICA STANDARD CEMENTED HIP SYSTEM (K926387)Techmedica, Inc.1994-02-01
HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (K925536)Orthomet, Inc.1994-01-07
TECHMEDICA STANDARD BIPOLAR SYSTEM (K925420)Techmedica, Inc.1993-09-28
CORIN BIPOLAR PROSTHESIS (K925897)Corin Orthopedic Products1993-08-09
CONSENSUS(TM) BIPOLAR SYSTEM (K922560)U.S. Medical Products, Inc.1992-09-11
BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM (K913632)Kirschner Medical Corp.1991-11-13
EXACTECH BIPOLAR HIP PROSTHESIS (K905370)Exactech, Inc.1991-02-27
ACUFIT TOTAL HIP (K904383)Acu Med, Inc.1990-12-20
MOORE TYPE ENDO PROSTHESIS (K900051)Lima Intl. Corp.1990-10-03
LEINBACH HIP PROSTHESIS (K896257)3M Company1990-01-19
BATEMAN UPF II HIP PROSTHESIS SYSTEM (K895120)3M Company1990-01-11
VS22 HIP PROSTHESIS (K896266)3M Company1989-11-22
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT (K893872)Johnson & Johnson Professionals, Inc.1989-09-11
P.S.A. FEMORAL HIP PROSTHESIS (K893959)Protek, Inc.1989-07-25
ZIMMER BEADED THREADED ACETABULAR CUP (K884658)Zimmer, Inc.1988-11-30
CORIN BIPOLAR PROSTHESIS (K881289)Orthopedic Systems, Inc.1988-06-29
IOI BIPOLAR PROSTHESIS (K873815)Intermedics Orthopedics1987-10-28
JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS (K873514)Johnson & Johnson Professionals, Inc.1987-09-24
BI-ARTICULAR II HIP DEVICE (K872019)Zimmer, Inc.1987-07-21
FEMORAL HEMI-HIP PROSTHESIS (K862460)Orthopaedic Device Corp.1986-10-06
KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD (K862057)Kirschner Medical Corp.1986-07-11
SLR BIPOLAR HIP ENDOPROSTHESIS (K861566)Dow Corning Wright1986-05-12
HOWMEDICA BIPOLAR PROSTHESIS (K861105)Howmedica Corp.1986-04-14
HOWMEDICA BIPOLAR PROSTHESIS (K855231)Howmedica Corp.1986-02-27
KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD (K853795)Kirschner Medical Corp.1985-11-22
HASTINGS BIPOLAR ENDOPROSTHESIS (K842344)Johnson & Johnson Professionals, Inc.1984-09-12
BDH BIPOLAR FEMORAL COMPONENT A3 (K833404)Carbomedics, Inc.1984-03-02
BIPOLAR HIP DEVICE (K833991)Zimmer1984-01-30
BIOMET BIPOLAR PROSTHESIS (K833175)Biomet, Inc.1983-12-22
SPECTRON CONVERSION ENDOPROSTHESIS CUP (K823726)Richard'S Medical Equip., Inc.1983-03-09
101 UNIVERSAL ENDOPROSTHESIS (K823482)Intermedics Orthopedics1983-02-07
SELF-CENTERING HIP (K812672)Depuy, Inc.1981-10-08
BI-CENTRIC BI-POLAR ENDOPROSTHESIS (K810062)Howmedica Corp.1981-01-26
3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM (K791823)3M Company1979-10-30
ENDOPROSTHESIS SYSTEM, VARIO-HEAD (K781735)Waldemar Link GmbH & Co. KG1978-10-24

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