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

FDA product code JDI · 558 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3350
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-05-23 – 2026-08-24

JDI 1984-10-02

DORR HIP PROSTHESIS FEMORAL COMPONENT

Applicant Carbomedics, Inc.

K number K842360

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JDI 1984-08-24

BIAS TOTAL HIP

Applicant Zimmer, Inc.

K number K842906

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JDI 1984-07-20

NEW JERSEY ACETABULAR COMPONENT &

Applicant Endomedics, Inc.

K number K842202

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JDI 1984-06-19

UNIVERSAL SELF-ALIGNING ACETABULAR COM

Applicant Orthopedic Equipment Co., Inc.

K number K834035

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JDI 1984-04-17

HARRIS-GALANTE POROUS TOTAL HIP SYS

Applicant Zimmer, Inc.

K number K840643

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JDI 1984-04-13

WEBER-STUHMER HIP PROSTHESIS STEM

Applicant Allo Pro Corp.

K number K841391

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JDI 1984-02-27

TOTAL HIP FEMORAL COMPONENT

Applicant Advanced Biosearch Assn.

K number K840150

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JDI 1984-02-17

SSA HIP PROSTHESIS

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K840357

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JDI 1984-01-13

ACETABULAR SCREW RING

Applicant Mecron Medical Products, Inc.

K number K833881

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JDI 1983-12-22

GALANTE FIBER METAL TOTAL HIP

Applicant Zimmer, Inc.

K number K833912

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JDI 1983-10-04

FREEMAN ACETABULAR CUP

Applicant Depuy, Inc.

K number K832958

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JDI 1983-09-29

DOSIMETRIC RELEASE OF GAMMA RADIATION

Applicant Kirschner Medical Corp.

K number K832211

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JDI 1983-09-29

MMS ACETABULAR CUPS

Applicant 3M Company

K number K830361

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JDI 1983-09-20

SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL

Applicant Richards Manufacturer Co.

K number K831884

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JDI 1983-08-26

P.C.A. HIP SYSTEM

Applicant Howmedica Corp.

K number K831373

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JDI 1983-08-08

METAL-BACKED ACE TABULAR CUP

Applicant Kirschner Medical Corp.

K number K831986

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JDI 1983-07-12

INTERFERENCE MEDULLARY FIT -IMF-HIP

Applicant Depuy, Inc.

K number K831314

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JDI 1983-07-12

WEBER/STIIHMER FEMORAL HEAD PROSTHESIS

Applicant Allo Pro Corp.

K number K830948

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JDI 1983-06-24

MILWAUKEE AUSTIN MOORE TOTAL HIP

Applicant Biomet, Inc.

K number K830314

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JDI 1983-05-25

CFE TOTAL HIP FEMORAL COMPONENT

Applicant Biomet, Inc.

K number K830313

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JDI 1983-05-16

LUS ACETABULAR COMPONENT

Applicant Biomet, Inc.

K number K830209

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JDI 1983-05-09

HARRIS A.R. C. ACETABULAR CUP

Applicant Howmedica Corp.

K number K830857

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JDI 1983-05-02

CEMENTED 101 32 FEMORAL COMPONENT

Applicant Intermedics Orthopedics

K number K830750

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JDI 1983-04-19

POROCOAT DUAL-LOCK TOTAL HIP SYSTEM

Applicant Depuy, Inc.

K number K830004

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JDI 1983-03-09

TITANIUM M.E. MULLER TYPE TOTAL HIP

Applicant Boehringer Mannheim Corp.

K number K830356

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JDI 1983-03-09

SPECTRON NECK REPLACEMENT PROSTHESIS

Applicant Richard'S Medical Equip., Inc.

K number K823724

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JDI 1983-03-09

SPECTRON PROXIMAL FEMORAL PROSTHESIS

Applicant Richard'S Medical Equip., Inc.

K number K823723

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JDI 1983-03-08

SPECTRON PRIMARY STEM FEMORAL PROSTHES

Applicant Richard'S Medical Equip., Inc.

K number K823727

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JDI 1983-03-08

SPECTRON LONG, STRAIGHT FEMORAL PROSTHES

Applicant Richard'S Medical Equip., Inc.

K number K823722

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JDI 1983-01-21

SPECTRON METAL BACK ACETABULAR COMPONENT

Applicant Richard'S Medical Equip., Inc.

K number K823729

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JDI 1983-01-21

SPECTRON POLYETHYLENE ACCTUBULAR COMPON

Applicant Richard'S Medical Equip., Inc.

K number K823728

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JDI 1983-01-21

SPECTRON PROTRUSIO CUP

Applicant Richard'S Medical Equip., Inc.

K number K823725

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JDI 1983-01-17

HC 1M METALBACKED ACETABULAR CUP

Applicant Osteonics Corp.

K number K823419

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JDI 1983-01-14

CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES

Applicant Allo Pro Corp.

K number K822979

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JDI 1982-09-14

ZIMMER METAL BACKED ACETABULAR CUP

Applicant Zimmer, Inc.

K number K821893

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JDI 1982-08-20

POROCOAT STANDARD METAL BACKED CUP

Applicant Depuy, Inc.

K number K821714

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JDI 1982-08-20

POROCOAT LOW PROFILE METAL BACKED CUP

Applicant Depuy, Inc.

K number K821713

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JDI 1982-05-21

TITANIUM AUFRANC-TURNER ATS HIP SYS

Applicant Howmedica Corp.

K number K821369

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JDI 1982-04-29

CONTOUR II LINK SP TOTAL HIP PROSTHESIS

Applicant C.R. Bard, Inc.

K number K821066

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JDI 1982-01-22

AUFRANC-TURNER TYPE ACETABULAR COMPON

Applicant Intermedics Orthopedics

K number K813600

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JDI 1981-11-20

CEMENT RING

Applicant Biomet, Inc.

K number K813089

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JDI 1981-10-20

HIP STEM SYSTEM TITANIUM ALLOY

Applicant Osteonics Corp.

K number K812801

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JDI 1981-10-14

PROXIMAL INTERPHALANGEAL JOINT IMPLANT

Applicant Sutter Biomedical, Inc.

K number K802342

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JDI 1981-08-18

MIAMI, PROTRUSIO RING

Applicant Zimmer, Inc.

K number K812182

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JDI 1981-06-24

EFTEKHAR CENTRALIZING PLUG

Applicant Zimmer, Inc.

K number K811293

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JDI 1981-05-15

COLLARLESS TOTAL HIP FEMORAL COMP. SYS

Applicant Howmedica Corp.

K number K811151

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JDI 1981-02-10

EXETER TOTAL HIP SYSTEM

Applicant Howmedica Corp.

K number K803126

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JDI 1981-02-04

REINFORCED HIP CUP

Applicant Biomet, Inc.

K number K810120

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JDI 1981-01-08

FERNORAL HIP PROSTHESIS

Applicant Cintor Orthopaedic Div.

K number K803074

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JDI 1980-12-16

ORTRON 90* HIP PROSTHESIS

Applicant Cintor Orthopaedic Div.

K number K802627

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JDI 1980-12-11

AUFRANC-TURNER ATS TOTAL HIP SYSTEM

Applicant Howmedica Corp.

K number K802872

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JDI 1980-05-02

DUPUY CEMENT RESTRICTOR TRIALS & INSTR.

Applicant Depuy, Inc.

K number K800894

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JDI 1980-04-29

3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM

Applicant 3M Company

K number K800487

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JDI 1979-03-28

INTERPLANTA SP TOTAL HIP PROSTHESIS

Applicant Waldemar Link GmbH & Co. KG

K number K790488

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JDI 1978-03-21

CUP, ACETABULAR, LONG POSTERIOR WALL

Applicant Orthopedic Equipment Co., Inc.

K number K780398

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JDI 1978-03-06

TOTAL HIP SYSTEM, HARRIS HD2

Applicant Howmedica Corp.

K number K780317

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JDI 1978-01-20

PROSTHESIS, DOUBLE CUP

Applicant Depuy, Inc.

K number K780052

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JDI 1977-05-23

PROSTHESIS, HIP, TRAPEZOIDAL-28

Applicant Zimmer, Inc.

K number K770908

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