Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

FDA product code KWY · 97 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3390
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-10-24 – 2026-04-13

KWY 2026-04-13

b-ONE® Bipolar Head

Applicant B-One Ortho, Corp.

K number K253357

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KWY 2025-08-25

Maxx Libertas Bipolar Hip Head (Bipolar Hip)

Applicant Maxx Orthopedics, Inc.

K number K243634

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KWY 2023-12-19

CORAIL Cemented Femoral Stem

Applicant Depuy Ireland UC

K number K231526

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KWY 2023-03-23

SpaceFlex Acetabular Cup

Applicant G21, S.R.L.

K number K223441

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KWY 2022-07-20

Vario-Cup System

Applicant Waldemar Link GmbH & Co. KG

K number K221794

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KWY 2022-03-23

COPAL exchange G hip spacer

Applicant Heraeus Medical GmbH

K number K220492

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KWY 2020-04-17

Kyocera Bipolar Hip System

Applicant Kyocera Medical Technologies, Inc.

K number K200709

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KWY 2019-11-05

Fitmore Hip Stem

Applicant Zimmer GmbH

K number K192236

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KWY 2019-11-01

COPAL exchange G Hip and Knee Spacers

Applicant Heraeus Medical GmbH

K number K191016

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KWY 2019-09-17

iNSitu Bipolar Hip System

Applicant Theken Companies, LLC

K number K191297

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KWY 2019-08-28

Implantcast ic-Bipolar Head System

Applicant Implantcast GmbH

K number K191569

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KWY 2019-06-05

Corin BiPolar-i

Applicant Corin U.S.A. Limited

K number K183114

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KWY 2018-06-14

SurgTech Bipolar Head System

Applicant Surgtech, Inc.

K number K173455

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KWY 2018-02-23

ELEOS™ Bipolar Acetabular System

Applicant Onkos Surgical, Inc.

K number K180130

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KWY 2018-01-29

40-42mm BiPolar Head and 22mm Femoral Head

Applicant Signature Orthopaedics Pty, Ltd.

K number K163081

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KWY 2017-02-07

Fitmore® Hip Stem

Applicant Zimmer GmbH

K number K170072

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KWY 2016-04-07

U2 Bipolar Implant and 22mm Femoral Head

Applicant United Orthopedic Corporation

K number K152439

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KWY 2013-09-19

RENOVIS BIPOLAR HIP SYSTEM

Applicant Renovis Surgical Technologies, LLC

K number K131354

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KWY 2013-09-16

DEPUY CORAIL AMT HIP PROSTHESIS

Applicant Depuy France S.A.S.

K number K123991

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KWY 2012-11-05

TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT

Applicant Tgm Medical, Inc.

K number K121509

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KWY 2011-10-12

BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP

Applicant Corentec Co., Ltd.

K number K112019

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KWY 2010-12-03

BIOPRO POLAR HEAD

Applicant Biopro, Inc.

K number K100761

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KWY 2010-10-08

UNITED U2 BIPOLAR IMPLANT

Applicant United Orthopedic Corp.

K number K101670

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KWY 2010-05-28

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)

Applicant Omnlife Science

K number K100151

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KWY 2010-03-02

MEDACTA BIPOLAR HEAD

Applicant Medacta International S.A.

K number K091967

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KWY 2009-02-18

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)

Applicant Omni Life Science, Inc.

K number K082468

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KWY 2008-12-15

BIOPRO BIPOLAR HEAD, MODELS 18130-18152

Applicant Biopro, Inc.

K number K082705

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KWY 2008-10-31

STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT

Applicant Biomet Manufacturing Corp

K number K080979

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KWY 2008-07-08

ACCIN BIPOLAR HEAD SYSTEM

Applicant Accelerated Innovation, LLC

K number K080647

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KWY 2006-09-29

GLADIATOR BIPOLAR SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K062693

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KWY 2006-05-31

AESCULAP BIPOLAR ACETABULAR CUP

Applicant Aesculap, Inc.

K number K060707

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KWY 2005-12-16

STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM

Applicant Biomet, Inc.

K number K052990

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KWY 2005-08-29

U1 HIP SYSTEM - BIPOLAR

Applicant United Orthopedic Corp.

K number K050269

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KWY 2005-07-07

PIVOT BIPOLAR FEMORAL HEAD

Applicant Ortho Development Corp.

K number K050966

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KWY 2004-08-27

DURASUL BIPOLAR

Applicant Centerpulse Orthopedics, Inc.

K number K040947

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KWY 2003-01-23

SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM

Applicant Smith & Nephew, Inc.

K number K023743

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KWY 2002-03-08

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

Applicant Disc-O-Tech Medical Technologies, Ltd.

K number K014072

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KWY 2001-12-05

MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

Applicant Exactech, Inc.

K number K013211

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KWY 2001-02-05

ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS

Applicant Exactech, Inc.

K number K010081

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KWY 2000-12-15

M2A 32MM TAPER SYSTEM

Applicant Biomet, Inc.

K number K003363

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KWY 1999-09-10

TRI-POLAR SYSTEM

Applicant Biomet, Inc.

K number K991990

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KWY 1998-12-04

G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)

Applicant Johnson & Johnson Professionals, Inc.

K number K982812

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KWY 1998-11-25

PLUS BIPOLAR PROSTHESIS COCRMO

Applicant Plus Orthopedics

K number K982447

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KWY 1998-10-07

ODC B2 BIPOLAR CUP

Applicant Ortho Development Corp.

K number K982389

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KWY 1998-08-21

BIPOLAR FEMORAL HEAD

Applicant Whiteside Biomechanics, Inc.

K number K981238

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KWY 1998-05-29

J-FX BIPOLAR HEAD

Applicant Johnson & Johnson Professionals, Inc.

K number K980801

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KWY 1997-04-30

IMPLEX BIPOLAR HIP SYSTEM

Applicant Implex Corp.

K number K970447

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KWY 1997-04-21

ARTOS, DIPLOS SYSTEM

Applicant Turnkey Intergration USA, Inc.

K number K970284

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KWY 1996-12-16

ADVANTAGE MAPF HIP FEMORAL COMPONENT

Applicant Biomet, Inc.

K number K960643

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KWY 1996-12-09

ULTIMA FX FEMORAL HIP STEMS

Applicant Johnson & Johnson Professionals, Inc.

K number K963885

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KWY 1996-09-19

PRIMALOC CEMENTED HIP SYSTEM

Applicant Ortho Development Corp.

K number K962448

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KWY 1996-07-26

BI-LOC BIPOLAR CUP

Applicant Ortho Development Corp.

K number K961793

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KWY 1996-03-08

P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT

Applicant Johnson & Johnson Professionals, Inc.

K number K945518

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KWY 1996-01-26

PRIMALOC CEMENTLESS HIP SYSTEM

Applicant Ortho Development Corp.

K number K953977

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KWY 1995-09-18

UHMWPE COMPONENTS-CHANGE IN PACKAGING

Applicant Depuy, Inc.

K number K940743

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KWY 1995-08-09

HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS

Applicant Encore Orthopedics, Inc.

K number K953510

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KWY 1995-04-10

P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR

Applicant Johnson & Johnson Professionals, Inc.

K number K945793

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KWY 1995-03-06

MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM

Applicant 3M Health Care, Ltd.

K number K941534

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KWY 1995-01-06

P.F.C. TOTAL HIP SYSTEM

Applicant Johnson & Johnson Professionals, Inc.

K number K944132

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KWY 1994-07-21

IOI COCR UNIPOLAR PROSTHESIS

Applicant Intermedics Orthopedics

K number K934159

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KWY 1994-06-09

P.F.C. BIPOLAR HIP SYSTEM

Applicant Johnson & Johnson Orthopaedics, Inc.

K number K931655

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KWY 1994-03-01

IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM

Applicant Howmedica Corp.

K number K925153

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KWY 1994-02-01

TECHMEDICA STANDARD CEMENTED HIP SYSTEM

Applicant Techmedica, Inc.

K number K926387

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KWY 1994-01-07

HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM

Applicant Orthomet, Inc.

K number K925536

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KWY 1993-09-28

TECHMEDICA STANDARD BIPOLAR SYSTEM

Applicant Techmedica, Inc.

K number K925420

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KWY 1993-08-09

CORIN BIPOLAR PROSTHESIS

Applicant Corin Orthopedic Products

K number K925897

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KWY 1992-09-11

CONSENSUS(TM) BIPOLAR SYSTEM

Applicant U.S. Medical Products, Inc.

K number K922560

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KWY 1991-11-13

BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM

Applicant Kirschner Medical Corp.

K number K913632

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KWY 1991-02-27

EXACTECH BIPOLAR HIP PROSTHESIS

Applicant Exactech, Inc.

K number K905370

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KWY 1990-12-20

ACUFIT TOTAL HIP

Applicant Acu Med, Inc.

K number K904383

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KWY 1990-10-03

MOORE TYPE ENDO PROSTHESIS

Applicant Lima Intl. Corp.

K number K900051

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KWY 1990-01-19

LEINBACH HIP PROSTHESIS

Applicant 3M Company

K number K896257

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KWY 1990-01-11

BATEMAN UPF II HIP PROSTHESIS SYSTEM

Applicant 3M Company

K number K895120

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KWY 1989-11-22

VS22 HIP PROSTHESIS

Applicant 3M Company

K number K896266

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KWY 1989-09-11

P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT

Applicant Johnson & Johnson Professionals, Inc.

K number K893872

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KWY 1989-07-25

P.S.A. FEMORAL HIP PROSTHESIS

Applicant Protek, Inc.

K number K893959

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KWY 1988-11-30

ZIMMER BEADED THREADED ACETABULAR CUP

Applicant Zimmer, Inc.

K number K884658

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KWY 1988-06-29

CORIN BIPOLAR PROSTHESIS

Applicant Orthopedic Systems, Inc.

K number K881289

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KWY 1987-10-28

IOI BIPOLAR PROSTHESIS

Applicant Intermedics Orthopedics

K number K873815

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KWY 1987-09-24

JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS

Applicant Johnson & Johnson Professionals, Inc.

K number K873514

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KWY 1987-07-21

BI-ARTICULAR II HIP DEVICE

Applicant Zimmer, Inc.

K number K872019

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KWY 1986-10-06

FEMORAL HEMI-HIP PROSTHESIS

Applicant Orthopaedic Device Corp.

K number K862460

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KWY 1986-07-11

KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD

Applicant Kirschner Medical Corp.

K number K862057

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KWY 1986-05-12

SLR BIPOLAR HIP ENDOPROSTHESIS

Applicant Dow Corning Wright

K number K861566

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KWY 1986-04-14

HOWMEDICA BIPOLAR PROSTHESIS

Applicant Howmedica Corp.

K number K861105

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KWY 1986-02-27

HOWMEDICA BIPOLAR PROSTHESIS

Applicant Howmedica Corp.

K number K855231

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KWY 1985-11-22

KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD

Applicant Kirschner Medical Corp.

K number K853795

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KWY 1984-09-12

HASTINGS BIPOLAR ENDOPROSTHESIS

Applicant Johnson & Johnson Professionals, Inc.

K number K842344

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KWY 1984-03-02

BDH BIPOLAR FEMORAL COMPONENT A3

Applicant Carbomedics, Inc.

K number K833404

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KWY 1984-01-30

BIPOLAR HIP DEVICE

Applicant Zimmer

K number K833991

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KWY 1983-12-22

BIOMET BIPOLAR PROSTHESIS

Applicant Biomet, Inc.

K number K833175

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KWY 1983-03-09

SPECTRON CONVERSION ENDOPROSTHESIS CUP

Applicant Richard'S Medical Equip., Inc.

K number K823726

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KWY 1983-02-07

101 UNIVERSAL ENDOPROSTHESIS

Applicant Intermedics Orthopedics

K number K823482

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KWY 1981-10-08

SELF-CENTERING HIP

Applicant Depuy, Inc.

K number K812672

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KWY 1981-01-26

BI-CENTRIC BI-POLAR ENDOPROSTHESIS

Applicant Howmedica Corp.

K number K810062

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KWY 1979-10-30

3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM

Applicant 3M Company

K number K791823

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KWY 1978-10-24

ENDOPROSTHESIS SYSTEM, VARIO-HEAD

Applicant Waldemar Link GmbH & Co. KG

K number K781735

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