Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

FDA product code MEH · 158 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: 1990-12-20 – 2026-08-10

MEH 1998-12-02

OSTEONICS RESTORATION HA HIP STEMS

Applicant Osteonics Corp.

K number K983870

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MEH 1998-07-09

OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

Applicant Osteonics Corp.

K number K982032

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MEH 1998-05-27

OSTEONICS ANTEVERTED NECK HA HIP STEMS

Applicant Osteonics Corp.

K number K980766

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MEH 1998-03-05

ESOP S/C FEMORAL STEM

Applicant Fournitures Hospitalieres

K number K964878

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MEH 1997-10-01

DISTALLY FIXED HIP STEM

Applicant Sulzer Orthopedics, Inc.

K number K971523

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MEH 1997-07-08

KAR

Applicant Landos, Inc.

K number K961732

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MEH 1997-05-22

OSTEONICS ACETABULAR WEDGE SYSTEM

Applicant Osteonics Corp.

K number K971422

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MEH 1997-04-22

OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM

Applicant Osteonics Corp.

K number K970394

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MEH 1997-04-03

ATLAS III ACETABULAR CUP

Applicant Fournitures Hospitalieres

K number K961388

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MEH 1997-02-28

HA GLOBAL TAPER (GT) TAPERED HIP STEM

Applicant Smith & Nephew, Inc., Orthopaedic Div.

K number K970337

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MEH 1996-12-19

OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)

Applicant Osteonics Corp.

K number K963959

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MEH 1996-04-25

APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)

Applicant Intermedics Orthopedics

K number K954800

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MEH 1996-01-18

PCA +15MM MODULAR FEMORAL HEAD

Applicant Howmedica Corp.

K number K955305

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MEH 1996-01-17

OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES

Applicant Osteonics Corp.

K number K951517

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MEH 1995-11-22

OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM

Applicant Osteonics Corp.

K number K954023

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MEH 1995-09-06

OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES

Applicant Osteonics Corp.

K number K951671

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MEH 1995-09-01

OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES

Applicant Osteonics Corp.

K number K951932

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MEH 1995-08-09

OSTEONICS RESTORATION MONOLITHIC HIP STEM

Applicant Osteonics Corp.

K number K951291

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MEH 1995-06-06

OSTEONICS OMNIFIT AD-HA HIP STEM SERIES

Applicant Osteonics Corp.

K number K941366

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MEH 1995-05-25

DEPUY CDH PROSTHESIS

Applicant Depuy, Inc.

K number K945844

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MEH 1995-04-10

OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES

Applicant Osteonics Corp.

K number K946234

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MEH 1995-04-10

OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES

Applicant Osteonics Corp.

K number K944836

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MEH 1995-03-17

OSTEONICS(R) THREADED HA ACETABULAR SHELLS

Applicant Osteonics Corp.

K number K945691

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MEH 1995-03-15

OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM

Applicant Osteonics Corp.

K number K942900

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MEH 1995-03-06

RESTORATION HA ACETABULAR CUP SERIES

Applicant Osteonics Corp.

K number K943957

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MEH 1994-11-02

SUMMIT TOTAL HIP SYSTEM

Applicant Kirschner Medical Corp.

K number K942891

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MEH 1994-09-01

TECHMEDICA CONTINUUM HIP WITH HA COATING

Applicant Techmedica, Inc.

K number K932017

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MEH 1994-07-22

ETEX HA HIP REPLACEMENT SYSTEM

Applicant Etex Corp.

K number K935696

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MEH 1994-07-22

UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED

Applicant Implantology Corp.

K number K934729

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MEH 1994-07-13

F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM

Applicant Implex Corp.

K number K935990

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MEH 1994-07-13

CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM

Applicant U.S. Medical Products, Inc.

K number K935453

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MEH 1994-04-05

CL HIP STEM H/A COATED

Applicant Lima Intl. Corp.

K number K922613

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MEH 1994-03-17

HA TI-FIT ACETABULAR AND FEMORAL COMPONENT

Applicant Smith & Nephew Richards, Inc.

K number K922621

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MEH 1994-02-14

STABILITY FEMORAL PROSTHESIS W/HAP

Applicant Depuy, Inc.

K number K915655

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MEH 1993-11-08

HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE

Applicant Zimmer, Inc.

K number K925607

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MEH 1993-10-22

CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING

Applicant Depuy, Inc.

K number K926299

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MEH 1993-10-15

H-220 PRESS-FIT ACETABULAR CUP SYSTEM

Applicant Implex Corp.

K number K926134

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MEH 1993-05-05

HYDROXYLAPATITE INFINITY(R)

Applicant Dow Corning Wright

K number K920969

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MEH 1992-12-24

PERFECTA TOTAL HIP SYSTEM, HA COATED

Applicant Orthomet, Inc.

K number K915190

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MEH 1992-08-07

INTER-HA HIP PROSTHESIS

Applicant Kirschner Medical Corp.

K number K921672

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MEH 1992-05-28

LSF HA COATED FEMORAL HIP

Applicant Implant Technology, Inc.

K number K915617

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MEH 1992-02-03

HYDROXYAPATITE INFINITY TROCHANTERIC MODULE

Applicant Dow Corning Wright

K number K915350

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MEH 1992-02-03

KINAMED ATH-HA & ATH-HA LONG TOTAL HIP

Applicant Kinamed, Inc.

K number K914843

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MEH 1991-12-30

S-ROM ZT HA PROXIMAL FEMORAL SLEEVE

Applicant Joint Medical Products Corp.

K number K912713

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MEH 1991-12-09

HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT

Applicant Smith & Nephew Richards, Inc.

K number K913916

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MEH 1991-10-11

HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)

Applicant Biomet, Inc.

K number K912370

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MEH 1991-10-11

HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)

Applicant Biomet, Inc.

K number K912369

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MEH 1991-10-04

DIMENSION-HA HIP PROSTHESIS

Applicant Kirschner Medical Corp.

K number K912922

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MEH 1991-10-04

HA MCCUTCHEN SLT HIP SYSTEM

Applicant Dow Corning Wright

K number K912452

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MEH 1991-08-29

HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC

Applicant Zimmer, Inc.

K number K912263

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MEH 1991-08-16

OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP

Applicant Osteonics Corp.

K number K912654

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MEH 1991-08-16

OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C

Applicant Osteonics Corp.

K number K911728

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MEH 1991-07-24

HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT

Applicant Howmedica Corp.

K number K912395

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MEH 1991-07-01

OMNIFIT II EPF HIP STEM SERIES

Applicant Osteonics Corp.

K number K911585

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MEH 1991-06-07

HYDROXYAPATITE COATED PROFILE(R) HIP STEM

Applicant Depuy, Inc.

K number K910156

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MEH 1991-03-26

PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING

Applicant Intermedics Orthopedics

K number K910755

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MEH 1991-03-04

APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM

Applicant Intermedics Orthopedics

K number K905781

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MEH 1990-12-20

THE OMNIFIT EPF HIP JOINT FEMORAL STEM

Applicant Osteonics Corp.

K number K896047

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