Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA product code LZO · 509 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3353
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1985-03-05 – 2026-09-17

LZO 1995-08-08

STELKAST ALL POLYETHYLENE ACETABULAR CUP

Applicant Stelkast Company

K number K953169

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LZO 1995-07-03

V40 ZIRCONIA FEMORAL HEADS

Applicant Howmedica Corp.

K number K952418

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LZO 1995-06-30

ZIRCONIA ARTICUL/EZE FEMORAL BALLS

Applicant Depuy, Inc.

K number K952088

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LZO 1995-03-20

HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS

Applicant Howmedica, Inc.

K number K946026

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LZO 1995-03-06

OSTEONICS RESTORATION MONOLITHIC HIP STEM

Applicant Osteonics Corp.

K number K943774

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LZO 1995-02-14

NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM

Applicant Intermedics Orthopedics

K number K945516

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LZO 1995-01-19

CDH HIP STEM

Applicant Howmedica Corp.

K number K945096

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LZO 1995-01-19

APC FEMORAL COMPONENT

Applicant Howmedica Corp.

K number K945095

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LZO 1995-01-19

HNR-PC HIP

Applicant Howmedica Corp.

K number K945094

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LZO 1995-01-19

P.C.A. E-SERIES HIP- CEMENTLESS USE

Applicant Howmedica, Inc.

K number K945093

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LZO 1995-01-19

P.C.A.PRIMARY HIP- CEMENTLESS USE

Applicant Howmedica Corp.

K number K945092

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LZO 1995-01-19

HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD

Applicant Howmedica Corp.

K number K945090

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LZO 1995-01-19

SENTRY TOTAL HIP

Applicant Howmedica Corp.

K number K945089

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LZO 1995-01-18

HOWMEDICA ALUMINA FEMORAL HEAD

Applicant Howmedica Corp.

K number K945091

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LZO 1995-01-12

ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD

Applicant Zimmer, Inc.

K number K944601

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LZO 1994-12-15

HOWMEDICA SENTRY S TOTAL HIP SYSTEM

Applicant Howmedica, Inc.

K number K935913

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LZO 1994-12-09

APR II NON POROUS HIP STEM

Applicant Intermedics Orthopedics

K number K944209

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LZO 1994-11-28

ZIRCONIA CERAMIC FEMORAL HEAD

Applicant Smith & Nephew Richards, Inc.

K number K935921

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LZO 1994-11-14

MODULAR CERAMIC FEMORAL HEAD

Applicant Stelkast Company

K number K936256

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LZO 1994-10-17

ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)

Applicant Biomet, Inc.

K number K943586

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LZO 1994-10-14

SOLUTION BOWED FEMORAL HIP PROTSTHESIS

Applicant Depuy, Inc.

K number K933942

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LZO 1994-10-06

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

Applicant Johnson & Johnson Orthopaedics, Inc.

K number K935452

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LZO 1994-10-04

APR II FEMORAL COMPONENT (VARIOUS)

Applicant Intermedics Orthopedics

K number K942330

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LZO 1994-09-28

P.F.C. CERAMIC HIP HEAD

Applicant Johnson & Johnson Orthopaedics, Inc.

K number K933275

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LZO 1994-09-12

TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS

Applicant Landos, Inc.

K number K933108

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LZO 1994-08-18

CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM

Applicant U.S. Medical Products, Inc.

K number K935193

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LZO 1994-07-12

SOLUTION HIP

Applicant Depuy, Inc.

K number K941942

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LZO 1994-07-12

5/8 POROCOAT AML HIP POROCOAT POROUS COATING

Applicant Depuy, Inc.

K number K941847

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LZO 1994-07-06

STABILITY HIP STEM WITH POROCOAT

Applicant Depuy, Inc.

K number K934457

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LZO 1994-06-16

MORPHOMETRIC TOTAL HIP PROSTHESIS

Applicant Landos, Inc.

K number K935185

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LZO 1994-06-15

TITAN DYSPLASIC TOTAL HIP PROSTHESIS

Applicant Landos, Inc.

K number K932935

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LZO 1994-06-14

EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT

Applicant Exactech, Inc.

K number K931617

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LZO 1994-05-27

SLT FEMORAL HEAD

Applicant Dow Corning Wright

K number K932222

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LZO 1994-05-18

KIRSCHNER ZIRCONIA FEMORAL HEAD

Applicant Kirschner Medical Corp.

K number K934694

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LZO 1994-05-18

CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM

Applicant U.S. Medical Products, Inc.

K number K933499

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LZO 1994-05-16

EUROFORM TOTAL HIP PROSTHESIS

Applicant Landos, Inc.

K number K933567

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LZO 1994-04-19

APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP

Applicant Intermedics Orthopedics

K number K933203

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LZO 1994-04-19

LINK CERAMIC HEADS 12/14 X 32MM

Applicant Link America, Inc.

K number K931571

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LZO 1994-03-30

KINAMED REALITY TOTAL HIP SYSTEM

Applicant Kinamed, Inc.

K number K922247

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LZO 1994-03-29

TECHMEDICA CONTINUUM HIP SYSTEM

Applicant Techmedica, Inc.

K number K931929

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LZO 1994-03-28

LINK CERAMIC HEADS 14/16 X 32MM

Applicant Link America, Inc.

K number K931572

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LZO 1994-03-10

OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM

Applicant Osteonics Corp.

K number K932519

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LZO 1994-03-10

ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM

Applicant Depuy, Inc.

K number K926395

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LZO 1994-03-10

ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)

Applicant Biomet, Inc.

K number K925345

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LZO 1994-02-22

ZIRCONIA CERAMIC FEMORAL HEAD

Applicant Smith & Nephew Richards, Inc.

K number K930788

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LZO 1994-02-16

INTEGRAL TOTAL HIP SYSTEM

Applicant Biomet, Inc.

K number K921225

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LZO 1994-02-16

BIMETRIC TOTAL HIP SYSTEM

Applicant Biomet, Inc.

K number K921224

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LZO 1994-02-16

MALLORY-HEAD TOTAL HIP SYSTEM

Applicant Biomet, Inc.

K number K921181

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LZO 1994-02-09

P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET

Applicant Johnson & Johnson Orthopaedics, Inc.

K number K931189

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LZO 1994-01-07

SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS

Applicant Encore Orthopedics, Inc.

K number K930963

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LZO 1994-01-07

BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED

Applicant Biopro, Inc.

K number K925682

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LZO 1993-10-04

P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR

Applicant Johnson & Johnson Orthopaedics, Inc.

K number K930712

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LZO 1993-07-27

MULLER STRAIGHT STEM FEMORAL PROSTHESIS

Applicant Techmedica, Inc.

K number K923808

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LZO 1993-06-22

WALKER HIP PROSTHESIS

Applicant Zimmer, Inc.

K number K915222

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LZO 1993-06-14

TOTAL HIP PROTHESIS FEMORAL COMPONENT

Applicant Intermedics Orthopedics

K number K923734

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LZO 1993-05-05

INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD

Applicant Dow Corning Wright

K number K920968

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LZO 1993-04-20

OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD

Applicant Osteonics Corp.

K number K925695

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LZO 1993-02-12

CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION

Applicant Dow Corning Wright

K number K925512

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LZO 1992-12-07

ORTHOMET PERFECTA TOTAL HIP SYSTEM

Applicant Orthomet, Inc.

K number K923583

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LZO 1992-11-06

PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD

Applicant Orthomet, Inc.

K number K921836

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LZO 1992-11-04

ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER

Applicant Biomet, Inc.

K number K915641

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LZO 1992-11-03

KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL

Applicant Kinamed, Inc.

K number K920290

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LZO 1992-10-30

KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL

Applicant Kinamed, Inc.

K number K920219

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LZO 1992-10-22

S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD

Applicant Joint Medical Products Corp.

K number K921111

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LZO 1992-10-20

OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD

Applicant Osteonics Corp.

K number K915396

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LZO 1992-10-15

BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM

Applicant Biopro, Inc.

K number K920145

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LZO 1992-08-31

CERAMIC FEMORAL HEAD

Applicant Dow Corning Wright

K number K920593

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LZO 1992-05-18

FELDMUHLE CERAMIC HEAD

Applicant Link America, Inc.

K number K920756

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LZO 1992-05-15

HOWEDICA ZIRCONIA FEMORAL HEAD

Applicant Howmedica Corp.

K number K920577

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LZO 1992-02-19

KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL

Applicant Kinamed, Inc.

K number K915310

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LZO 1992-02-19

KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL

Applicant Kinamed, Inc.

K number K915309

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LZO 1992-01-31

HOWMEDICA ALUMINA FEMORAL HEAD

Applicant Pfizer Hospital Products Group, Inc.

K number K915184

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LZO 1992-01-16

ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF

Applicant Biomet, Inc.

K number K913420

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LZO 1992-01-13

ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER

Applicant Zimmer, Inc.

K number K914676

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LZO 1992-01-13

EXACTECH CERAMIC FEMORAL HEAD COMPONENT

Applicant Exactech, Inc.

K number K914574

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LZO 1991-12-24

LIMA 28MM CERAMIC HEAD, MODIFICATION

Applicant Turnkey Intergration USA, Inc.

K number K912985

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LZO 1991-12-05

KINAMED CTN STEM

Applicant Kinamed, Inc.

K number K914237

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LZO 1991-11-27

BIOPRO ZIRALLOY MODULAR FEMORAL HEADS

Applicant Biopro, Inc.

K number K912641

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LZO 1991-11-22

TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS

Applicant Intermedics Orthopedics

K number K913633

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LZO 1991-08-12

KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL

Applicant Kinamed, Inc.

K number K912295

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LZO 1991-04-15

ZIRCONIA CERAMIC MODULAR HEADS

Applicant Biomet, Inc.

K number K905687

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LZO 1991-04-12

FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)

Applicant Turnkey Intergration USA, Inc.

K number K910547

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LZO 1991-04-09

FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)

Applicant Turnkey Intergration USA, Inc.

K number K910548

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LZO 1991-03-07

ZIMMER CERAMIC FEMORAL HEADS

Applicant Zimmer, Inc.

K number K905739

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LZO 1991-01-30

TOTAL HIP FEMORAL COMPONENT

Applicant Intermedics Orthopedics

K number K905260

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LZO 1991-01-14

DCW MODULAR PROXIMAL FEMORAL SYSTEM

Applicant Dow Corning Wright

K number K904028

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LZO 1991-01-09

CTH STABILO TOTAL HIP REPLACEMENT SYSTEM

Applicant Kinamed, Inc.

K number K903976

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LZO 1990-08-09

OSTEONICS PS HEAD AND NECK HIP STEM SERIES

Applicant Osteonics Corp.

K number K902712

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LZO 1990-06-08

KINAMED CEMENTED CTH STEM

Applicant Kinamed, Inc.

K number K902074

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LZO 1990-06-08

KINAMED CEMENTED ATH-LONG STEM

Applicant Kinamed, Inc.

K number K902073

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LZO 1990-06-05

LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE

Applicant Lima Intl. Corp.

K number K896850

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LZO 1990-05-09

MODULAR HIP SYSTEM

Applicant Richards Medical Co., Inc.

K number K900628

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LZO 1990-03-19

KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL

Applicant Kinamed, Inc.

K number K894904

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LZO 1990-02-06

WEBER PERMALOCK

Applicant Allo Pro Corp.

K number K896669

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LZO 1989-12-14

KIM MODULAR FEMORAL HIP PROSTHESIS

Applicant Dow Corning Wright

K number K895399

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LZO 1989-11-20

ZIRCONIA CERAMIC HEAD ADD'L SIZES

Applicant Richards Medical Co., Inc.

K number K896204

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LZO 1989-10-19

BIOLOX CERAMIC BALL

Applicant Allo Pro Corp.

K number K892644

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LZO 1989-10-12

OMNIFIT CERAMIC MORSE TAPER HEAD

Applicant Osteonics Corp.

K number K894694

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LZO 1989-09-26

CERAMIC FEMORAL HEAD

Applicant Dow Corning Wright

K number K893685

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LZO 1989-09-01

ATH CERAMIC UHMWPE TOTAL HIP SYSTEM

Applicant Kinamed, Inc.

K number K890472

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