FDA 510(k) Applications for Medical Device Product Code "JDL"
(Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))

FDA 510(k) Number Applicant Device Name Decision Date
K920738 ACE ORTHOPEDIC MANUFACTURING CO. ACE 100 DEGREES TUBULAR PLATE 07/27/1992
K844482 ADVANCED BIOSEARCH ASSN. MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT 02/19/1985
K830662 ADVANCED BIOSEARCH ASSN. NATURAL LOCK ACETABULAR COMPONENT 04/11/1983
K892640 ARROW INTL., INC. PNEUMOTHORAX KIT, MOTIFICATION 10/11/1989
K921139 BIOMET, INC. HEALEY REVISION COMPONENT SYSTEM 07/01/1992
K042841 BIOMET, INC. M2A/C2A ACETABULAR SYSTEM 12/21/2004
K842893 CARBOMEDICS, INC. DORR HIP PROSTHESIS, ACETABULAR COMPON 11/08/1984
K861264 DEVCOM, INC. JOINT MEASUREMENT INDICATOR 04/15/1986
K920929 DOW CORNING WRIGHT POLY INSERT 20 DEGREE 05/05/1993
K894965 DOW CORNING WRIGHT POROUS-COATED TITANIUM ACETABULAR CUP 11/17/1989
K950542 ENCORE ORTHOPEDICS, INC. METAL BACKED ACETABULAR COMPONENT 05/25/1995
K831792 ENDOMEDICS, INC. SELF-ALIGNING ACETABULAR COMPONENT 09/20/1984
K895607 EXACTECH, INC. POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT 11/17/1989
K790274 HOWMEDICA CORP. BG PROXIMAL FEMUR 03/26/1979
K921384 HOWMEDICA CORP. PCA ACETABULAR INSERT II 06/25/1992
K934440 HOWMEDICA CORP. PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES 02/22/1994
K930833 HOWMEDICA CORP. PCA(R) SOLID BACK ACETABULA SHELL 02/22/1994
K770472 HOWMEDICA CORP. PROSTHESIS, VIDAL TOTAL HIP 03/17/1977
K915527 IMPLANTOLOGY CORP. CPS ACETABULAR COMPONENT 06/24/1993
K915529 IMPLANTOLOGY CORP. FPC/SFPC/RFPC ACETABULAR COMPONENT 07/13/1993
K813599 INTERMEDICS ORTHOPEDICS 101-32 FEMORAL COMPONENT 01/22/1982
K850793 INTERMEDICS ORTHOPEDICS MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA 05/09/1985
K944769 JOHNSON & JOHNSON PROFESSIONALS, INC. P.F.C. APICAL PLUG 12/08/1994
K931676 JOINT MEDICAL PRODUCTS CORP. S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG 05/18/1994
K854107 KIRSCHNER MEDICAL CORP. DIMENSION TOTAL HIP PROSTHESIS POROUS COATED 03/10/1986
K855042 KIRSCHNER MEDICAL CORP. KM-3 ACETABULAR COMPONENT 03/14/1986
K870867 KIRSCHNER MEDICAL CORP. KM-4(TM) METAL-BACKED ACETABULAR CUP 05/08/1987
K852369 LINK AMERICA, INC. LIDGRER-LUND ACETABULAR SOCKETS 06/18/1985
K854935 LINK AMERICA, INC. LINK METAL-BACKED ACETABULAR CUPS 03/05/1986
K870234 ORTHOPAEDIC DEVICE CORP. P.T.H. METAL-BACKED ACETABULAR CUP 03/20/1987
K922861 OSTEO TECHNOLOGY, INC. BIOMETRIC SCREW FIXATION CUP 05/12/1993
K920868 OSTEONICS CORP. ACETABULAR DOME AND SCREW HOLE PLUGS 05/26/1992
K942809 OSTEONICS CORP. ACETABULAR DOME HOLE PLUGS 09/20/1994
K850352 OSTEONICS CORP. MICRO-STRUC. ACETABULAR COMPON- MC2P 04/25/1985
K935669 REGULATORY & MARKETING SERVICES, INC. SYRIGENE PRE-FILLED SYRINGE 02/18/1994
K896614 SYNERGY ORTHOPAEDICS INTL., INC. S.A.F. ACETABULAR CUP WITH POROUS COATING 01/09/1990
K925181 TECHMEDICA, INC. TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP 02/05/1993
K922561 U.S. MEDICAL PRODUCTS, INC. CONSENSUS(TM) TOTAL HIP SYSTEM 07/21/1993
K051348 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE TOTAL FEMORAL HEAD 08/19/2005
K061844 WRIGHT MEDICAL TECHNOLOGY, INC. DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER 12/06/2006
K070785 WRIGHT MEDICAL TECHNOLOGY, INC. DYNASTY ACETABULAR SYSTEM 07/11/2007
K004043 WRIGHT MEDICAL TECHNOLOGY, INC. METAL TRANSCEND ARTICULATION SYSTEM 07/13/2001
K051995 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR RENAISSANCE HIP STEM 08/22/2005
K041586 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR S HIP STEM 07/09/2004
K041114 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR TAPERED HIP STEM 05/28/2004
K073499 ZIMMER, INC. VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES 08/07/2008


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