Prosthesis, Hip, Hemi-, Femoral, Metal

FDA product code KWL · 107 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3360
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-11-15 – 2026-07-24

KWL 2026-07-24

REMEDY POLY+PLUS SNAP FIT Acetabular Cup

Applicant Osteoremedies, LLC

K number K262290

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KWL 2026-05-15

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

Applicant Depuy Ireland UC

K number K260536

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KWL 2025-12-23

OsteoRemedies Hip Spacer System

Applicant Osteoremedies, LLC

K number K253675

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KWL 2025-08-06

InterSpace GV Hip Spacer

Applicant Tecres S.P.A.

K number K252326

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KWL 2025-06-12

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

Applicant Biocomposites, Ltd.

K number K242865

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KWL 2024-02-15

COPAL® exchange G hip spacer; COPAL® G+V

Applicant Heraeus Medical GmbH

K number K234028

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KWL 2022-10-21

UHR Bipolar Implants, Restoration GAP II Implants

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K222632

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KWL 2020-01-10

OsteoRemedies Hip Spacer System

Applicant Osteoremedies, LLC

K number K192995

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KWL 2019-08-23

REMEDY Acetabular Cup

Applicant Osteoremedies, LLC

K number K191981

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KWL 2018-08-29

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement

Applicant Osteoremedies, LLC

K number K172906

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KWL 2018-02-22

Remedy Acetabular Cup

Applicant Osteoremedies, LLC

K number K173967

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KWL 2012-04-05

2GC HIP/KNEE MODULAR SPACER

Applicant Mandell Horwitz Consultants, LLC

K number K112470

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KWL 2011-09-20

Spacer-G and Spacer-K

Applicant Tecres S.P.A.

K number K101356

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KWL 2011-08-04

CORIN OPTIMOM MODULAR HEAD

Applicant Corin USA

K number K111911

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KWL 2008-05-22

SPACER-G TEMPORARY HIP PROSTHESIS

Applicant Tecres S.P.A.

K number K062273

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KWL 2007-09-10

CORIN ADAPTOR SLEEVE

Applicant Howmedica Osteonics Corp.

K number K071471

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KWL 2007-04-03

CORIN UNIPOLAR MODULAR HEAD

Applicant Corin USA

K number K063791

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KWL 2006-09-12

SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD

Applicant Smith & Nephew, Inc.

K number K062408

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KWL 2006-07-17

SMITH & NEPHEW MODULAR FEMORAL HEAD

Applicant Smith & Nephew, Inc.

K number K061243

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KWL 2005-01-27

SOLITUDE UNIPOLAR HEAD

Applicant Ortho Development Corp.

K number K042973

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KWL 2004-01-22

SPACER G TEMPORARY HIP PROSTHESIS

Applicant Exactech, Inc.

K number K031841

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KWL 2003-05-30

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

Applicant Disc-O-Tech Medical Technologies, Ltd.

K number K030972

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KWL 2003-04-01

CONSENSUS UNIPOLAR HEAD, COCR

Applicant Hayes Medical, Inc.

K number K030205

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KWL 2002-01-25

UNITRAX MODULAR UNIPOLAR SYSTEM

Applicant Howmedica Osteonics Corp.

K number K014226

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KWL 1999-09-01

UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE

Applicant Howmedica Osteonics Corp.

K number K992570

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KWL 1999-03-15

PLUS FRACTURE HEAD PROSTHESIS

Applicant Plus Orthopedics

K number K990309

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KWL 1999-02-24

OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE

Applicant Osteonics Corp.

K number K984585

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KWL 1999-01-19

THE NEW BIO-MOORE ENDO HEADS

Applicant Biomet, Inc.

K number K984028

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KWL 1998-08-21

ARGOMEDICAL BIPOLAR SYSTEM

Applicant Stelkast Company

K number K981451

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KWL 1998-03-16

OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM

Applicant Osteonics Corp.

K number K974807

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KWL 1997-12-18

FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES

Applicant Encore Orthopedics, Inc.

K number K973614

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KWL 1997-07-23

ULTIMA TPS CEMENTED STEM

Applicant Johnson & Johnson International

K number K965198

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KWL 1997-01-24

ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES

Applicant Johnson & Johnson Professionals, Inc.

K number K965156

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KWL 1996-09-23

PRIME MODULAR ENDO HEAD

Applicant Orthopaedic Innovations, Inc.

K number K962646

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KWL 1996-03-27

OPTEON UNIPOLAR

Applicant Exactech, Inc.

K number K960538

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KWL 1996-01-30

JOHNSON & JOHNSON AUSTIN MOORE STEM

Applicant Johnson & Johnson Professionals, Inc.

K number K955385

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KWL 1995-11-30

OSTEONICS UNIPOLAR ENDO HEAD

Applicant Osteonics Corp.

K number K954534

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KWL 1995-11-15

UNITRAX V40 MODULAR ADAPTOR

Applicant Howmedica Corp.

K number K954077

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KWL 1995-08-14

OSTEONICS RESTORATION CEMENTED HIP STEM SERIES

Applicant Osteonics Corp.

K number K943778

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KWL 1995-06-07

ULTIMA AUGMENTED UHMWPE CUP

Applicant Johnson & Johnson Professionals, Inc.

K number K950563

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KWL 1995-05-25

LINK SADDLE PROTHESIS

Applicant Turnkey Intergration USA, Inc.

K number K951355

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KWL 1994-10-07

CORIN THOMPSON PROSTHESIS, MODIFICATION

Applicant Corin Orthopedic Products

K number K931753

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KWL 1994-10-07

CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION

Applicant Corin Orthopedic Products

K number K931752

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KWL 1994-09-29

ULTIMA UNIPOLAR MODULAR HEAD

Applicant Johnson & Johnson Orthopaedics, Inc.

K number K940190

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KWL 1994-04-25

ZIRCONIUM ALLOY UNI-POLAR HEAD

Applicant Smith & Nephew Richards, Inc.

K number K934353

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KWL 1993-08-25

TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT

Applicant Orthomet, Inc.

K number K924050

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KWL 1993-03-31

CONTOUR FEMORAL HIP STEM WITH POROCOAT

Applicant Depuy, Inc.

K number K926120

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KWL 1993-02-12

ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM

Applicant Johnson & Johnson Orthopaedics, Inc.

K number K924379

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KWL 1992-08-11

OSTRONCS HEMI-HIP STEM SERIES

Applicant Osteonics Corp.

K number K922146

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KWL 1992-06-08

OMNIFIT M-HA HIP STEM SERIES

Applicant Stryker Corp.

K number K920231

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KWL 1992-06-08

OMNIFLEX M-HA HIP STEM SERIES

Applicant Stryker Corp.

K number K920193

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KWL 1992-03-23

PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT

Applicant Orthomet, Inc.

K number K915868

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KWL 1991-01-18

MTS FEMORAL HIP SYSTEM

Applicant 3M Company

K number K903877

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KWL 1991-01-11

MODULAR UNIPOLAR SYSTEM

Applicant Howmedica Corp.

K number K902365

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KWL 1990-12-11

AUSTIN MOORE TYPE HIP PROTHESIS

Applicant O'Tec Corp.

K number K905349

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KWL 1990-12-11

THOMPSON TYPE HIP PROSTHESIS

Applicant O'Tec Corp.

K number K905334

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KWL 1990-10-11

PROFILE COLLARED HIP PROSTHESIS

Applicant Depuy, Inc.

K number K904119

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KWL 1990-09-13

KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD

Applicant Kinamed, Inc.

K number K903885

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KWL 1990-09-13

KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD

Applicant Kinamed, Inc.

K number K903884

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KWL 1990-07-30

AUSTIN MOORE TYPE HIP PROSTHESIS

Applicant Onyx Medical Corp.

K number K903241

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KWL 1990-07-30

THOMPSON TYPE HIS PROSTHESIS

Applicant Onyx Medical Corp.

K number K903240

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KWL 1990-05-02

PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA

Applicant Howmedica Corp.

K number K896853

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KWL 1990-04-30

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT

Applicant Johnson & Johnson International

K number K900638

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KWL 1989-12-29

EVOLUTION HIP SYSTEM

Applicant Dow Corning Wright

K number K896105

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KWL 1989-12-01

BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM

Applicant Biopro, Inc.

K number K895886

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KWL 1989-05-16

AML(R) COLLARLESS LATERALIZED FEMORAL HIP

Applicant Depuy, Inc.

K number K891482

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KWL 1989-02-27

MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

Applicant Protek, Inc.

K number K884889

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KWL 1989-02-08

NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI

Applicant Protek, Inc.

K number K884789

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KWL 1988-09-22

HIP FRACTURE STEM SYSTEM

Applicant Howmedica Corp.

K number K883179

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KWL 1988-02-03

ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS

Applicant Orthomet, Inc.

K number K874915

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KWL 1987-08-26

BIOPRO FEMORAL HIP COMPONENT

Applicant Biopro, Inc.

K number K872535

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KWL 1987-08-24

PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT

Applicant Depuy, Inc.

K number K872776

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KWL 1987-08-18

POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS

Applicant Depuy, Inc.

K number K872025

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KWL 1987-08-07

TRI-LOCK MODIFIED FEMORAL PROSTHESIS

Applicant Depuy, Inc.

K number K872878

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KWL 1987-06-09

ORTHOMET AUSTIN-MOORE SYSTEM

Applicant Orthomet, Inc.

K number K871656

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KWL 1987-01-28

BROOKER BIO-GROOVE FEMORAL COMPONENT

Applicant Biomet, Inc.

K number K864085

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KWL 1986-02-27

BIO-FIT HIP SYSTEM

Applicant Richards Medical Co., Inc.

K number K854791

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KWL 1986-02-11

FEMORAL HEMI-HIP PROSTHESES

Applicant Orthopaedic Device Corp.

K number K855228

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KWL 1985-09-24

MUELLER CURVED STEM HEMI-PROSTHESIS

Applicant Protek, Inc.

K number K853662

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KWL 1985-08-15

POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT

Applicant Biomet, Inc.

K number K852584

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KWL 1985-07-30

NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS

Applicant Osteonics Corp.

K number K844818

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KWL 1985-06-28

BTM TOTAL HIP SYSTEM

Applicant Kirschner Medical Corp.

K number K852420

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KWL 1985-05-28

V.E.P. HIP -VARIABLE ENDO-PROSTHESIS

Applicant Unitas Ent.

K number K850928

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KWL 1985-04-23

TF-II HIP PROSTHESIS

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K843995

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KWL 1985-04-19

AUSTIN-MOORE MODULAR HIP PROSTHESIS

Applicant Biomet, Inc.

K number K845025

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KWL 1985-03-12

MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS

Applicant Mecron Medical Products, Inc.

K number K844488

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KWL 1985-02-19

MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR

Applicant Mecron Medical Products, Inc.

K number K844487

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KWL 1985-02-19

MECRON MRC-HEADLESS FEMORAL COMPONENT

Applicant Mecron Medical Products, Inc.

K number K844486

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KWL 1984-12-20

WHITESIDE ORTHOLOC TOTAL HIP FEMORAL

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K842559

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KWL 1984-11-19

UNILOC

Applicant American Ortomed Corp.

K number K842465

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KWL 1984-07-20

NEW JERSEY FEMORAL STEM

Applicant Endomedics, Inc.

K number K842234

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KWL 1984-06-25

PENNSYLVANIA HOSPITAL HIP SYS

Applicant Biomet, Inc.

K number K841437

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KWL 1984-03-19

MODIFIED HPS HIP PROSTHESIS

Applicant Depuy, Inc.

K number K833599

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KWL 1984-01-10

BDH UNIPOLAR FEMORAL COMPONENT A2

Applicant Carbomedics, Inc.

K number K833403

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KWL 1983-10-06

STRAIGHT STEM FEMORAL HEAD PROSTHESIS

Applicant Proteck, Inc.

K number K831851

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KWL 1983-09-20

HIP PROSTHESIS -VARIOUS

Applicant The Oec Group

K number K831420

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KWL 1983-03-10

AUFRANC-TURNER ATS TOTAL HIP SYSTEM

Applicant Howmedica Corp.

K number K830307

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KWL 1982-12-03

METAL KNEE & HIP PROSTHESIS

Applicant Zimmer, Inc.

K number K823051

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KWL 1982-08-20

IOI 32 TM FEMORAL COMPONENT

Applicant Intermedics Orthopedics

K number K822321

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KWL 1982-08-19

KAMPNER FEMORAL COMPONENT

Applicant Intermedics Orthopedics

K number K822320

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