Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

FDA product code LWJ · 81 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: 1984-01-27 – 2012-10-12

LWJ 2012-10-12

UNISYN PLUS HIP STEM

Applicant Consensus Orthopedics, Inc.

K number K120595

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LWJ 2011-03-09

TRINITY ACETABULAR SYSTEM

Applicant Corin USA

K number K103518

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LWJ 2009-04-21

NOVATION CFS PRESS-FIT AND CEMENTED STEMS

Applicant Exactech, Inc.

K number K090764

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LWJ 2008-09-09

METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD

Applicant Aesculap Implant Systems, Inc.

K number K082146

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LWJ 2007-01-31

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT

Applicant Hayes Medical, Inc.

K number K070061

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LWJ 2007-01-16

U2 HIP STEM, TI PLASMA SPRAY

Applicant United Orthopedic Corp.

K number K062978

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LWJ 2006-12-21

UNISYN HA PLASMA MODULAR HIP

Applicant Hayes Medical, Inc.

K number K062383

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LWJ 2006-08-18

EXCIA

Applicant Aesculap, Inc.

K number K061699

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LWJ 2005-11-18

BETACONE HIP PROSTHESIS SYSTEM

Applicant Waldemar Link GmbH & Co. KG

K number K051826

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LWJ 2005-08-15

U2 ACETABULAR COMPONENT

Applicant United Orthopedic Corp.

K number K050262

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LWJ 2005-03-16

EXCIA TOTAL HIP SYSTEM

Applicant Aesculap, Inc.

K number K042344

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LWJ 2005-01-25

Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED

Applicant Osteoimplant Technology, Inc.

K number K040685

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LWJ 2004-07-28

QUATRO M FEMORAL COMPONENT

Applicant Whiteside Biomechanics, Inc.

K number K033313

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LWJ 2003-09-23

MODULAR PLUS HIP STEM

Applicant Plus Orthopedics

K number K032709

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LWJ 2003-09-22

PROCLASS PRESS FIT HIP STEM

Applicant Stelkast Company

K number K032110

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LWJ 2003-04-24

MODIFICATION TO MODULAR PLUS REVISION STEM

Applicant Plus Orthopedics

K number K030971

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LWJ 2003-03-20

GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER

Applicant Howmedica Osteonics Corp.

K number K023692

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LWJ 2003-02-05

DEPUY SUMMIT BASIC PRESS-FIT HIP STEM

Applicant DePuy Orthopaedics, Inc.

K number K030122

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LWJ 2003-01-15

UNI HIP STEM

Applicant Plus Orthopedics

K number K024134

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LWJ 2002-10-02

PROXILOCK HIP PROSTHESIS; SIZE 12/36

Applicant Implex Corp.

K number K022966

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LWJ 2001-02-23

TRITON HIP SYSTEM

Applicant Hayes Medical, Inc.

K number K003649

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LWJ 2001-02-15

TRI-FIT FEMORAL STEM

Applicant Corin USA

K number K010243

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LWJ 2000-12-13

PRO-FEMUR R

Applicant Wrightmedicaltechnologyinc

K number K003016

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LWJ 2000-12-11

EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP

Applicant Plus Orthopedics

K number K994146

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LWJ 2000-12-04

ACETABULAR PLATES

Applicant Encore Orthopedics, Inc.

K number K002941

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LWJ 2000-11-15

INTER-OP DURASUL ACETABULAR INSERTS (4MM)

Applicant Sulzer Orthopedics, Inc.

K number K002575

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LWJ 2000-09-28

MODIFICATION TO PROVIDENT HIP SYSTEM

Applicant Stelkast Company

K number K002796

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LWJ 2000-08-16

ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT

Applicant Exactech, Inc.

K number K002141

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LWJ 2000-08-07

THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ

Applicant Implex Corp.

K number K001471

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LWJ 2000-07-27

MODIFICATION TO PROVIDENT HIP SYSTEM

Applicant Stelkast Company

K number K001745

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LWJ 2000-07-25

SL-PLUS AND SLR-PLUS STEMS

Applicant Plus Orthopedics

K number K001942

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LWJ 2000-05-04

MODULAR-PLUS REVISION STEM

Applicant Plus Orthopedics

K number K994126

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LWJ 1999-11-16

HOWMEDICA OSTEONICS FEMORAL HEADS

Applicant Howmedica Osteonics Corp.

K number K993601

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LWJ 1998-10-21

OSTEONICS EXTENDED FEMORAL BEARING HEAD

Applicant Osteonics Corp.

K number K982936

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LWJ 1997-12-18

LATERAL FLARE INTERNAL COLLAR (LFIC)

Applicant Pro-Lfic, LLC

K number K971900

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LWJ 1997-11-13

PLUS-FIT ACETABULAR CUP

Applicant Plus Orthopedics

K number K973077

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LWJ 1997-11-13

PLUS EPF ACETABULAR CUP

Applicant Hhl Consulting

K number K972931

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LWJ 1997-05-05

PRESS-FIT HIP STEM

Applicant Encore Orthopedics, Inc.

K number K964178

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LWJ 1996-10-24

PERFECTA REVISION HIP SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K955553

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LWJ 1996-10-23

CHROME COBALT BALL HEAD

Applicant Artos Medical Products GmbH

K number K962268

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LWJ 1996-10-23

SC, CEMENTLESS HIP SYSTEM

Applicant Artos Medical Products GmbH

K number K962034

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LWJ 1996-10-08

DELTA HIP PROSTHESIS

Applicant Zimmer, Inc.

K number K961378

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LWJ 1996-10-01

INTERMOORE FRACTURE HIP STEM (MODIFY)

Applicant Intermedics Orthopedics

K number K963155

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LWJ 1996-10-01

PRESS-FIT FLARED SHELL

Applicant Encore Orthopedics, Inc.

K number K960633

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LWJ 1996-08-08

SRRS PRESSED FIT FEMORAL REVISION COMPONENT

Applicant Stelkast Company

K number K960908

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LWJ 1996-02-15

INTERMOORE FRACTURE HIP STEM

Applicant Intermedics Orthopedics

K number K954854

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LWJ 1996-02-14

LFIC OR FETTO HIP

Applicant Zimmer, Inc.

K number K952776

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LWJ 1996-01-17

DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT

Applicant Stelkast Company

K number K953268

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LWJ 1995-07-17

FOUNDATION TEXTURED STEM

Applicant Encore Orthopedics, Inc.

K number K952297

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LWJ 1995-03-21

HOWMEDICA V40 22MM FEMORAL HEAD

Applicant Howmedica Corp.

K number K950541

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LWJ 1994-10-13

PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM

Applicant Orthomed

K number K931423

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LWJ 1994-04-28

COBALT CHROME GEMINI

Applicant Depuy, Inc.

K number K934909

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LWJ 1994-03-07

OSTEONICS 22MM, +10 NECK BEARING HEADS

Applicant Osteonics Corp.

K number K933359

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LWJ 1994-01-07

FUTURA TEXTURE-TRAKKED TOTAL HIP STEM

Applicant Arthronics, Inc.

K number K921382

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LWJ 1993-04-14

INTRINSIC STEM

Applicant Turnkey Intergration USA, Inc.

K number K923911

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LWJ 1992-04-01

MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.

Applicant Medimix Products, Inc.

K number K910664

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LWJ 1992-01-27

VENUS HIP

Applicant Turnkey Intergration USA, Inc.

K number K913708

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LWJ 1992-01-13

TI-FIT FEMORAL COMPONENT

Applicant Smith & Nephew Richards, Inc.

K number K914343

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LWJ 1991-03-14

HOWMEDICA HNR SYSTEM

Applicant Howmedica Corp.

K number K903563

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LWJ 1991-03-12

Q SYSTEM 28 HIP STEM

Applicant Turnkey Intergration USA, Inc.

K number K910010

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LWJ 1991-02-26

THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH

Applicant Depuy, Inc.

K number K905254

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LWJ 1991-02-15

GERI TOTAL HIP SYSTEM

Applicant Smith & Nephew Richards, Inc.

K number K905186

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LWJ 1990-09-14

ACSYS SHEARER ACETABULAR CUP PROSTHESIS

Applicant 3M Company

K number K900435

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LWJ 1990-09-14

ACSYS SELFTAP ACETABULAR CUP PROSTHESIS

Applicant 3M Company

K number K900262

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LWJ 1990-09-07

F-24 FEMORAL HIP PROSTHESIS

Applicant Med-Tek Corp.

K number K901687

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LWJ 1990-08-03

H.N. TOTAL HIP PROSTHESIS

Applicant Med-Tek Corp.

K number K901594

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LWJ 1989-11-03

KDR ACETABULAR COMPONENT

Applicant Osteonics Corp.

K number K895702

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LWJ 1989-10-13

FREEMAN TOTAL HIP SYSTEM RIDGED STEM

Applicant Orthopedic Systems, Inc.

K number K890331

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LWJ 1989-08-28

PREMIER-TOTAL HIP

Applicant Intermedics Orthopedics

K number K894051

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LWJ 1989-08-09

ARC-2F ACETABULAR CUP

Applicant Protek, Inc.

K number K893785

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LWJ 1989-07-28

GRIPPER II ACETABULAR CUP

Applicant Joint Medical Products Corp.

K number K893584

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LWJ 1989-06-08

CTI II STRAIGHT STEM

Applicant Orthopedic Systems, Inc.

K number K891539

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LWJ 1989-06-06

KDG ACETABULAR COMPONENT

Applicant Osteonics Corp.

K number K891262

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LWJ 1989-05-26

RESUBMITTED CLW ACETABULAR CUP W/SULMESH

Applicant Protek, Inc.

K number K883794

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LWJ 1989-02-08

MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)

Applicant Depuy, Inc.

K number K883661

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LWJ 1988-10-13

OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING

Applicant Osteonics Corp.

K number K883921

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LWJ 1988-10-06

HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT

Applicant Howmedica Corp.

K number K881983

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LWJ 1988-06-29

CORIN MODULAR MOORE STEM

Applicant Orthopedic Systems, Inc.

K number K881288

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LWJ 1988-04-22

S-ROM SUPERCUP ACETABULAR CUP

Applicant Joint Medical Products Corp.

K number K870088

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LWJ 1987-11-02

TI-FIT TOTAL HIP SYSTEM

Applicant Richards Medical Co., Inc.

K number K873797

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LWJ 1984-01-27

MICRO-STRUCTURED HS2P HIP STEMS

Applicant Osteonics Corp.

K number K833970

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