LWJ · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Orthopedic · 21 CFR 888.3360 · Class 2
Overview
| Product Code | LWJ |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Regulation | 21 CFR 888.3360 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
Classification Rationale
Class II.
Cleared Devices (81)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120595 | UNISYN PLUS HIP STEM | Consensus Orthopedics, Inc. | Oct 12, 2012 | SESE |
| K103518 | TRINITY ACETABULAR SYSTEM | Corin USA | Mar 9, 2011 | SESE |
| K090764 | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | Exactech, Inc. | Apr 21, 2009 | SESE |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | Sep 9, 2008 | SESE |
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | Hayes Medical, Inc. | Jan 31, 2007 | SESE |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | United Orthopedic Corp. | Jan 16, 2007 | SESE |
| K062383 | UNISYN HA PLASMA MODULAR HIP | Hayes Medical, Inc. | Dec 21, 2006 | SESE |
| K061699 | EXCIA | Aesculap, Inc. | Aug 18, 2006 | SESE |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Waldemar Link GmbH & Co. KG | Nov 18, 2005 | SESE |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | Aug 15, 2005 | SESE |
| K042344 | EXCIA TOTAL HIP SYSTEM | Aesculap, Inc. | Mar 16, 2005 | SESE |
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | Osteoimplant Technology, Inc. | Jan 25, 2005 | SESE |
| K033313 | QUATRO M FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | Jul 28, 2004 | SESE |
| K032709 | MODULAR PLUS HIP STEM | Plus Orthopedics | Sep 23, 2003 | SESE |
| K032110 | PROCLASS PRESS FIT HIP STEM | Stelkast Company | Sep 22, 2003 | SESE |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | Plus Orthopedics | Apr 24, 2003 | SESE |
| K023692 | GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER | Howmedica Osteonics Corp. | Mar 20, 2003 | SESE |
| K030122 | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM | DePuy Orthopaedics, Inc. | Feb 5, 2003 | SESE |
| K024134 | UNI HIP STEM | Plus Orthopedics | Jan 15, 2003 | SESE |
| K022966 | PROXILOCK HIP PROSTHESIS; SIZE 12/36 | Implex Corp. | Oct 2, 2002 | SESE |
| K003649 | TRITON HIP SYSTEM | Hayes Medical, Inc. | Feb 23, 2001 | SESE |
| K010243 | TRI-FIT FEMORAL STEM | Corin USA | Feb 15, 2001 | SESE |
| K003016 | PRO-FEMUR R | Wrightmedicaltechnologyinc | Dec 13, 2000 | SESE |
| K994146 | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP | Plus Orthopedics | Dec 11, 2000 | SESE |
| K002941 | ACETABULAR PLATES | Encore Orthopedics, Inc. | Dec 4, 2000 | SESE |
| K002575 | INTER-OP DURASUL ACETABULAR INSERTS (4MM) | Sulzer Orthopedics, Inc. | Nov 15, 2000 | SESE |
| K002796 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | Sep 28, 2000 | SESE |
| K002141 | ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT | Exactech, Inc. | Aug 16, 2000 | SESE |
| K001471 | THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ | Implex Corp. | Aug 7, 2000 | SESE |
| K001745 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | Jul 27, 2000 | SESE |
| K001942 | SL-PLUS AND SLR-PLUS STEMS | Plus Orthopedics | Jul 25, 2000 | SESE |
| K994126 | MODULAR-PLUS REVISION STEM | Plus Orthopedics | May 4, 2000 | SESE |
| K993601 | HOWMEDICA OSTEONICS FEMORAL HEADS | Howmedica Osteonics Corp. | Nov 16, 1999 | SESE |
| K982936 | OSTEONICS EXTENDED FEMORAL BEARING HEAD | Osteonics Corp. | Oct 21, 1998 | SESE |
| K971900 | LATERAL FLARE INTERNAL COLLAR (LFIC) | Pro-Lfic, LLC | Dec 18, 1997 | SESE |
| K973077 | PLUS-FIT ACETABULAR CUP | Plus Orthopedics | Nov 13, 1997 | SESE |
| K972931 | PLUS EPF ACETABULAR CUP | Hhl Consulting | Nov 13, 1997 | SESE |
| K964178 | PRESS-FIT HIP STEM | Encore Orthopedics, Inc. | May 5, 1997 | SESE |
| K955553 | PERFECTA REVISION HIP SYSTEM | Wrightmedicaltechnologyinc | Oct 24, 1996 | SESE |
| K962268 | CHROME COBALT BALL HEAD | Artos Medical Products GmbH | Oct 23, 1996 | SESE |
| K962034 | SC, CEMENTLESS HIP SYSTEM | Artos Medical Products GmbH | Oct 23, 1996 | SESE |
| K961378 | DELTA HIP PROSTHESIS | Zimmer, Inc. | Oct 8, 1996 | SESE |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Intermedics Orthopedics | Oct 1, 1996 | SESE |
| K960633 | PRESS-FIT FLARED SHELL | Encore Orthopedics, Inc. | Oct 1, 1996 | SESE |
| K960908 | SRRS PRESSED FIT FEMORAL REVISION COMPONENT | Stelkast Company | Aug 8, 1996 | SESE |
| K954854 | INTERMOORE FRACTURE HIP STEM | Intermedics Orthopedics | Feb 15, 1996 | SESE |
| K952776 | LFIC OR FETTO HIP | Zimmer, Inc. | Feb 14, 1996 | SESE |
| K953268 | DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT | Stelkast Company | Jan 17, 1996 | SESE |
| K952297 | FOUNDATION TEXTURED STEM | Encore Orthopedics, Inc. | Jul 17, 1995 | SESE |
| K950541 | HOWMEDICA V40 22MM FEMORAL HEAD | Howmedica Corp. | Mar 21, 1995 | SESE |
| K931423 | PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM | Orthomed | Oct 13, 1994 | SN |
| K934909 | COBALT CHROME GEMINI | Depuy, Inc. | Apr 28, 1994 | SESE |
| K933359 | OSTEONICS 22MM, +10 NECK BEARING HEADS | Osteonics Corp. | Mar 7, 1994 | SESE |
| K921382 | FUTURA TEXTURE-TRAKKED TOTAL HIP STEM | Arthronics, Inc. | Jan 7, 1994 | SESE |
| K923911 | INTRINSIC STEM | Turnkey Intergration USA, Inc. | Apr 14, 1993 | SESE |
| K910664 | MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. | Medimix Products, Inc. | Apr 1, 1992 | SESE |
| K913708 | VENUS HIP | Turnkey Intergration USA, Inc. | Jan 27, 1992 | SESE |
| K914343 | TI-FIT FEMORAL COMPONENT | Smith & Nephew Richards, Inc. | Jan 13, 1992 | SESE |
| K903563 | HOWMEDICA HNR SYSTEM | Howmedica Corp. | Mar 14, 1991 | SESE |
| K910010 | Q SYSTEM 28 HIP STEM | Turnkey Intergration USA, Inc. | Mar 12, 1991 | SESE |
| K905254 | THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH | Depuy, Inc. | Feb 26, 1991 | SN |
| K905186 | GERI TOTAL HIP SYSTEM | Smith & Nephew Richards, Inc. | Feb 15, 1991 | SESE |
| K900435 | ACSYS SHEARER ACETABULAR CUP PROSTHESIS | 3M Company | Sep 14, 1990 | SESE |
| K900262 | ACSYS SELFTAP ACETABULAR CUP PROSTHESIS | 3M Company | Sep 14, 1990 | SESE |
| K901687 | F-24 FEMORAL HIP PROSTHESIS | Med-Tek Corp. | Sep 7, 1990 | SESE |
| K901594 | H.N. TOTAL HIP PROSTHESIS | Med-Tek Corp. | Aug 3, 1990 | SESE |
| K895702 | KDR ACETABULAR COMPONENT | Osteonics Corp. | Nov 3, 1989 | SESE |
| K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM | Orthopedic Systems, Inc. | Oct 13, 1989 | SESE |
| K894051 | PREMIER-TOTAL HIP | Intermedics Orthopedics | Aug 28, 1989 | SESE |
| K893785 | ARC-2F ACETABULAR CUP | Protek, Inc. | Aug 9, 1989 | SN |
| K893584 | GRIPPER II ACETABULAR CUP | Joint Medical Products Corp. | Jul 28, 1989 | SN |
| K891539 | CTI II STRAIGHT STEM | Orthopedic Systems, Inc. | Jun 8, 1989 | SESE |
| K891262 | KDG ACETABULAR COMPONENT | Osteonics Corp. | Jun 6, 1989 | SESE |
| K883794 | RESUBMITTED CLW ACETABULAR CUP W/SULMESH | Protek, Inc. | May 26, 1989 | SESE |
| K883661 | MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) | Depuy, Inc. | Feb 8, 1989 | SN |
| K883921 | OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING | Osteonics Corp. | Oct 13, 1988 | SESE |
| K881983 | HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT | Howmedica Corp. | Oct 6, 1988 | SESE |
| K881288 | CORIN MODULAR MOORE STEM | Orthopedic Systems, Inc. | Jun 29, 1988 | SESE |
| K870088 | S-ROM SUPERCUP ACETABULAR CUP | Joint Medical Products Corp. | Apr 22, 1988 | SN |
| K873797 | TI-FIT TOTAL HIP SYSTEM | Richards Medical Co., Inc. | Nov 2, 1987 | SESE |
| K833970 | MICRO-STRUCTURED HS2P HIP STEMS | Osteonics Corp. | Jan 27, 1984 | SESE |
Top Applicants
- Plus Orthopedics — 7 clearances
- Osteonics Corp. — 6 clearances
- Stelkast Company — 5 clearances
- Encore Orthopedics, Inc. — 4 clearances
- Turnkey Intergration USA, Inc. — 3 clearances
