FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K082146 |
AESCULAP IMPLANT SYSTEMS, INC. |
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD |
09/09/2008 |
K061699 |
AESCULAP, INC. |
EXCIA |
08/18/2006 |
K042344 |
AESCULAP, INC. |
EXCIA TOTAL HIP SYSTEM |
03/16/2005 |
K962268 |
ARTOS MEDICAL PRODUCTS GMBH |
CHROME COBALT BALL HEAD |
10/23/1996 |
K962034 |
ARTOS MEDICAL PRODUCTS GMBH |
SC, CEMENTLESS HIP SYSTEM |
10/23/1996 |
K120595 |
CONSENSUS ORTHOPEDICS, INC. |
UNISYN PLUS HIP STEM |
10/12/2012 |
K010243 |
CORIN U.S.A. |
TRI-FIT FEMORAL STEM |
02/15/2001 |
K103518 |
CORIN U.S.A. |
TRINITY ACETABULAR SYSTEM |
03/09/2011 |
K030122 |
DEPUY ORTHOPAEDICS, INC. |
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM |
02/05/2003 |
K002941 |
ENCORE ORTHOPEDICS, INC. |
ACETABULAR PLATES |
12/04/2000 |
K960633 |
ENCORE ORTHOPEDICS, INC. |
PRESS-FIT FLARED SHELL |
10/01/1996 |
K964178 |
ENCORE ORTHOPEDICS, INC. |
PRESS-FIT HIP STEM |
05/05/1997 |
K002141 |
EXACTECH, INC. |
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT |
08/16/2000 |
K090764 |
EXACTECH, INC. |
NOVATION CFS PRESS-FIT AND CEMENTED STEMS |
04/21/2009 |
K070061 |
HAYES MEDICAL, INC. |
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT |
01/31/2007 |
K003649 |
HAYES MEDICAL, INC. |
TRITON HIP SYSTEM |
02/23/2001 |
K062383 |
HAYES MEDICAL, INC. |
UNISYN HA PLASMA MODULAR HIP |
12/21/2006 |
K972931 |
HHL CONSULTING |
PLUS EPF ACETABULAR CUP |
11/13/1997 |
K023692 |
HOWMEDICA OSTEONICS CORP. |
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER |
03/20/2003 |
K993601 |
HOWMEDICA OSTEONICS CORP. |
HOWMEDICA OSTEONICS FEMORAL HEADS |
11/16/1999 |
K022966 |
IMPLEX CORP. |
PROXILOCK HIP PROSTHESIS; SIZE 12/36 |
10/02/2002 |
K001471 |
IMPLEX CORP. |
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ |
08/07/2000 |
K954854 |
INTERMEDICS ORTHOPEDICS |
INTERMOORE FRACTURE HIP STEM |
02/15/1996 |
K963155 |
INTERMEDICS ORTHOPEDICS |
INTERMOORE FRACTURE HIP STEM (MODIFY) |
10/01/1996 |
K040685 |
OSTEOIMPLANT TECHNOLOGY, INC. |
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED |
01/25/2005 |
K982936 |
OSTEONICS CORP. |
OSTEONICS EXTENDED FEMORAL BEARING HEAD |
10/21/1998 |
K994146 |
PLUS ORTHOPEDICS |
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP |
12/11/2000 |
K030971 |
PLUS ORTHOPEDICS |
MODIFICATION TO MODULAR PLUS REVISION STEM |
04/24/2003 |
K032709 |
PLUS ORTHOPEDICS |
MODULAR PLUS HIP STEM |
09/23/2003 |
K994126 |
PLUS ORTHOPEDICS |
MODULAR-PLUS REVISION STEM |
05/04/2000 |
K973077 |
PLUS ORTHOPEDICS |
PLUS-FIT ACETABULAR CUP |
11/13/1997 |
K001942 |
PLUS ORTHOPEDICS |
SL-PLUS AND SLR-PLUS STEMS |
07/25/2000 |
K024134 |
PLUS ORTHOPEDICS |
UNI HIP STEM |
01/15/2003 |
K971900 |
PRO-LFIC LLC. |
LATERAL FLARE INTERNAL COLLAR (LFIC) |
12/18/1997 |
K953268 |
STELKAST COMPANY |
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT |
01/17/1996 |
K001745 |
STELKAST COMPANY |
MODIFICATION TO PROVIDENT HIP SYSTEM |
07/27/2000 |
K002796 |
STELKAST COMPANY |
MODIFICATION TO PROVIDENT HIP SYSTEM |
09/28/2000 |
K032110 |
STELKAST COMPANY |
PROCLASS PRESS FIT HIP STEM |
09/22/2003 |
K960908 |
STELKAST COMPANY |
SRRS PRESSED FIT FEMORAL REVISION COMPONENT |
08/08/1996 |
K002575 |
SULZER ORTHOPEDICS, INC. |
INTER-OP DURASUL ACETABULAR INSERTS (4MM) |
11/15/2000 |
K050262 |
UNITED ORTHOPEDIC CORP. |
U2 ACETABULAR COMPONENT |
08/15/2005 |
K062978 |
UNITED ORTHOPEDIC CORP. |
U2 HIP STEM, TI PLASMA SPRAY |
01/16/2007 |
K051826 |
WALDEMAR LINK GMBH & CO. KG |
BETACONE HIP PROSTHESIS SYSTEM |
11/18/2005 |
K033313 |
WHITESIDE BIOMECHANICS, INC. |
QUATRO M FEMORAL COMPONENT |
07/28/2004 |
K955553 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PERFECTA REVISION HIP SYSTEM |
10/24/1996 |
K003016 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PRO-FEMUR R |
12/13/2000 |
K961378 |
ZIMMER, INC. |
DELTA HIP PROSTHESIS |
10/08/1996 |
K952776 |
ZIMMER, INC. |
LFIC OR FETTO HIP |
02/14/1996 |