Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

FDA product code JDL · 45 cleared devices

Class 3 Orthopedic

Regulation: 21 CFR 888.3320
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-03-17 – 2008-08-07

JDL 2008-08-07

VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES

Applicant Zimmer, Inc.

K number K073499

View details →

JDL 2007-07-11

DYNASTY ACETABULAR SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K070785

View details →

JDL 2006-12-06

DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER

Applicant Wrightmedicaltechnologyinc

K number K061844

View details →

JDL 2005-08-22

PROFEMUR RENAISSANCE HIP STEM

Applicant Wrightmedicaltechnologyinc

K number K051995

View details →

JDL 2005-08-19

CONSERVE TOTAL FEMORAL HEAD

Applicant Wrightmedicaltechnologyinc

K number K051348

View details →

JDL 2004-12-21

M2A/C2A ACETABULAR SYSTEM

Applicant Biomet, Inc.

K number K042841

View details →

JDL 2004-07-09

PROFEMUR S HIP STEM

Applicant Wrightmedicaltechnologyinc

K number K041586

View details →

JDL 2004-05-28

PROFEMUR TAPERED HIP STEM

Applicant Wrightmedicaltechnologyinc

K number K041114

View details →

JDL 2001-07-13

METAL TRANSCEND ARTICULATION SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K004043

View details →

JDL 1995-05-25

METAL BACKED ACETABULAR COMPONENT

Applicant Encore Orthopedics, Inc.

K number K950542

View details →

JDL 1994-12-08

P.F.C. APICAL PLUG

Applicant Johnson & Johnson Professionals, Inc.

K number K944769

View details →

JDL 1994-09-20

ACETABULAR DOME HOLE PLUGS

Applicant Osteonics Corp.

K number K942809

View details →

JDL 1994-05-18

S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG

Applicant Joint Medical Products Corp.

K number K931676

View details →

JDL 1994-02-22

PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES

Applicant Howmedica Corp.

K number K934440

View details →

JDL 1994-02-22

PCA(R) SOLID BACK ACETABULA SHELL

Applicant Howmedica Corp.

K number K930833

View details →

JDL 1994-02-18

SYRIGENE PRE-FILLED SYRINGE

Applicant Regulatory & Marketing Services, Inc.

K number K935669

View details →

JDL 1993-07-21

CONSENSUS(TM) TOTAL HIP SYSTEM

Applicant U.S. Medical Products, Inc.

K number K922561

View details →

JDL 1993-07-13

FPC/SFPC/RFPC ACETABULAR COMPONENT

Applicant Implantology Corp.

K number K915529

View details →

JDL 1993-06-24

CPS ACETABULAR COMPONENT

Applicant Implantology Corp.

K number K915527

View details →

JDL 1993-05-12

BIOMETRIC SCREW FIXATION CUP

Applicant Osteo Technology, Inc.

K number K922861

View details →

JDL 1993-05-05

POLY INSERT 20 DEGREE

Applicant Dow Corning Wright

K number K920929

View details →

JDL 1993-02-05

TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP

Applicant Techmedica, Inc.

K number K925181

View details →

JDL 1992-07-01

HEALEY REVISION COMPONENT SYSTEM

Applicant Biomet, Inc.

K number K921139

View details →

JDL 1992-06-25

PCA ACETABULAR INSERT II

Applicant Howmedica Corp.

K number K921384

View details →

JDL 1992-05-26

ACETABULAR DOME AND SCREW HOLE PLUGS

Applicant Osteonics Corp.

K number K920868

View details →

JDL 1990-01-09

S.A.F. ACETABULAR CUP WITH POROUS COATING

Applicant Synergy Orthopaedics Intl., Inc.

K number K896614

View details →

JDL 1989-11-17

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

Applicant Exactech, Inc.

K number K895607

View details →

JDL 1989-11-17

POROUS-COATED TITANIUM ACETABULAR CUP

Applicant Dow Corning Wright

K number K894965

View details →

JDL 1989-10-11

PNEUMOTHORAX KIT, MOTIFICATION

Applicant Arrow Intl., Inc.

K number K892640

View details →

JDL 1987-05-08

KM-4(TM) METAL-BACKED ACETABULAR CUP

Applicant Kirschner Medical Corp.

K number K870867

View details →

JDL 1987-03-20

P.T.H. METAL-BACKED ACETABULAR CUP

Applicant Orthopaedic Device Corp.

K number K870234

View details →

JDL 1986-04-15

JOINT MEASUREMENT INDICATOR

Applicant Devcom, Inc.

K number K861264

View details →

JDL 1986-03-14

KM-3 ACETABULAR COMPONENT

Applicant Kirschner Medical Corp.

K number K855042

View details →

JDL 1986-03-10

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

Applicant Kirschner Medical Corp.

K number K854107

View details →

JDL 1986-03-05

LINK METAL-BACKED ACETABULAR CUPS

Applicant Link America, Inc.

K number K854935

View details →

JDL 1985-06-18

LIDGRER-LUND ACETABULAR SOCKETS

Applicant Link America, Inc.

K number K852369

View details →

JDL 1985-05-09

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA

Applicant Intermedics Orthopedics

K number K850793

View details →

JDL 1985-04-25

MICRO-STRUC. ACETABULAR COMPON- MC2P

Applicant Osteonics Corp.

K number K850352

View details →

JDL 1985-02-19

MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT

Applicant Advanced Biosearch Assn.

K number K844482

View details →

JDL 1984-11-08

DORR HIP PROSTHESIS, ACETABULAR COMPON

Applicant Carbomedics, Inc.

K number K842893

View details →

JDL 1984-09-20

SELF-ALIGNING ACETABULAR COMPONENT

Applicant Endomedics, Inc.

K number K831792

View details →

JDL 1983-04-11

NATURAL LOCK ACETABULAR COMPONENT

Applicant Advanced Biosearch Assn.

K number K830662

View details →

JDL 1982-01-22

101-32 FEMORAL COMPONENT

Applicant Intermedics Orthopedics

K number K813599

View details →

JDL 1979-03-26

BG PROXIMAL FEMUR

Applicant Howmedica Corp.

K number K790274

View details →

JDL 1977-03-17

PROSTHESIS, VIDAL TOTAL HIP

Applicant Howmedica Corp.

K number K770472

View details →