KWA · Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Orthopedic · 21 CFR 888.3330 · Class 3
Overview
| Product Code | KWA |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
| Regulation | 21 CFR 888.3330 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).
Classification Rationale
Class III.
Cleared Devices (114)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122778 | PROFEMUR Z REVISION HIP STEM | Wrightmedicaltechnologyinc | Oct 11, 2012 | SESE |
| K121544 | DYNASTY BIOFOAM SHELL | Wrightmedicaltechnologyinc | Jul 30, 2012 | SESE |
| K113271 | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | Biomet Manufacturing, Inc. | May 18, 2012 | SESE |
| K113322 | CONSERVE THIN SHELL | Wrightmedicaltechnologyinc | Feb 3, 2012 | SESE |
| K112080 | PRESERVE HIP STEM | Wrightmedicaltechnologyinc | Dec 28, 2011 | SESE |
| K112150 | PROFEMUR GLADIATOR HA HIP STEM | Wrightmedicaltechnologyinc | Nov 23, 2011 | SESE |
| K113019 | PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER | Wrightmedicaltechnologyinc | Nov 10, 2011 | SESE |
| K111910 | GLADIATOR HIP STEM | Wrightmedicaltechnologyinc | Oct 14, 2011 | SESE |
| K110836 | CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY | Zimmer GmbH | Oct 7, 2011 | SESE |
| K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | Biomet Manufacturing Corp | Sep 30, 2011 | SESE |
| K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | Wrightmedicaltechnologyinc | Aug 19, 2011 | SESE |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM | Wrightmedicaltechnologyinc | Aug 19, 2011 | SESE |
| K110399 | GLADIATOR PLASMA CLASSIC HIP STEM | Wrightmedicaltechnologyinc | May 10, 2011 | SESE |
| K110029 | CONSERVE BIO FOAM SHELL | Wrightmedicaltechnologyinc | Apr 19, 2011 | SESE |
| K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | Biomet Manufacturing Corp | Jan 21, 2011 | SESE |
| K102565 | ANTERIOR APPROACH HIP SURGERY INSTRUMENTS | Wrightmedicaltechnologyinc | Dec 22, 2010 | SESE |
| K100469 | ARCOS INTERLOCKING DISTAL STEMS | Biomet Manufacturing Corp | Dec 7, 2010 | SESE |
| K101086 | TAPERLOC COMPLETE | Biomet, Inc. | Sep 3, 2010 | SESE |
| K101475 | COMPRESS ANTI-ROTATION SPINDLES | Biomet Manufacturing Corp | Jun 18, 2010 | SESE |
| K093235 | RINGLOC + HYBRID ACETABULAR SYSTEM | Biomet, Inc. | Apr 30, 2010 | SESE |
| K092331 | DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; | Encore Medical L.P. | Mar 3, 2010 | SESE |
| K091003 | ZIMMER MMC CUP | Zimmer GmbH | Nov 24, 2009 | SESE |
| K091973 | METASUL TAPER LINERS, METASUL FEMORAL HEADS | Zimmer GmbH | Nov 17, 2009 | SESE |
| K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | Biomet, Inc. | Sep 25, 2009 | SESE |
| K091423 | PROFEMUR HIP SYSTEM MODULAR NECKS | Wrightmedicaltechnologyinc | Aug 25, 2009 | SESE |
| K083651 | REVELATION STEM, MODEL 427-21/42-080/180 | Encore Medical L.P. | Mar 13, 2009 | SESE |
| K083642 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | Mar 6, 2009 | SESE |
| K082924 | DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER | Wrightmedicaltechnologyinc | Mar 6, 2009 | SESE |
| K082585 | DEPUY ASPHERE M-SPEC HEAD | DePuy Orthopaedics, Inc. | Dec 4, 2008 | SESE |
| K082446 | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS | Biomet, Inc. | Oct 15, 2008 | SESE |
| K080991 | DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | Jul 2, 2008 | SESE |
| K081090 | PROFEMUR LX 5/8 COATED HIP STEM | Wrightmedicaltechnologyinc | May 15, 2008 | SESE |
| K081007 | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM | Zimmer, Inc. | May 6, 2008 | SESE |
| K080663 | PROFEMUR LX REVISION 5/8 COATED HIP STEM | Wrightmedicaltechnologyinc | Apr 8, 2008 | SESE |
| K073637 | PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS | Biomet Manufacturing Corp | Mar 20, 2008 | SESE |
| K071723 | ZIMMER POROLOCK MIS STEM | Zimmer GmbH | Mar 7, 2008 | SESE |
| K073413 | DEPUY ASR 300 ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | Jan 30, 2008 | SESE |
| K071856 | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES | Zimmer, Inc. | Jul 30, 2007 | SESE |
| K070221 | FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 | Encore Medical L.P. | Apr 4, 2007 | SESE |
| K070274 | ECHO BI-METRIC PRESS-FIT STEMS | Biomet Manufacturing Corp | Apr 3, 2007 | SESE |
| K062994 | LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS | Biomet Manufacturing Corp | Mar 9, 2007 | SESE |
| K070359 | DEPUY ASR TAPER SLEEVE ADAPTER | DePuy Orthopaedics, Inc. | Mar 6, 2007 | SESE |
| K063614 | ALTRA FX HIP SYSTEM | Biomet Manufacturing Corp | Feb 20, 2007 | SESE |
| K063251 | ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY | Zimmer, Inc. | Jan 24, 2007 | SESE |
| K062998 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) | Biomet Manufacturing Corp | Jan 19, 2007 | SESE |
| K062426 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | Dec 15, 2006 | SESE |
| K063414 | MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 | Encore Medical L.P. | Dec 12, 2006 | SESE |
| K063002 | ALTRA PRESS-FIT HIP SYSTEM | Biomet Manufacturing Corp | Oct 31, 2006 | SESE |
| K062995 | M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT | Biomet Manufacturing Corp | Oct 31, 2006 | SESE |
| K061221 | DUPUY S-ROM STD HIP STEM PROSTHESIS | DePuy Orthopaedics, Inc. | Aug 28, 2006 | SESE |
| K061423 | M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS | Biomet Manufacturing Corp | Jul 27, 2006 | SESE |
| K060358 | PROFEMUR TL HIP STEM | Wrightmedicaltechnologyinc | May 10, 2006 | SESE |
| K060356 | CONSERVE PLUS QUADRAFIX ACETABULAR SHELL | Wrightmedicaltechnologyinc | Apr 18, 2006 | SESE |
| K053536 | DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS | Zimmer GmbH | Mar 16, 2006 | SESE |
| K052915 | PROFEMUR XTR HIP STEM | Wrightmedicaltechnologyinc | Jan 27, 2006 | SESE |
| K053588 | PROFEMUR LX HIP STEM | Wrightmedicaltechnologyinc | Jan 13, 2006 | SESE |
| K052320 | ENCORE CLP OFFSET TOTAL HIP SYSTEM | Encore Medical Corporation | Dec 30, 2005 | SESE |
| K052888 | POROUS TITANIUM ACETABULAR AUGMENTS | Biomet Manufacturing Corp | Dec 6, 2005 | SESE |
| K050124 | POROUS COATED ACETABULAR COMPONENTS | Biomet, Inc. | Oct 4, 2005 | SESE |
| K043099 | LINEAGE HA ACETABULAR SHELLS | Wrightmedicaltechnologyinc | Sep 29, 2005 | SESE |
| K043547 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM | Biomet, Inc. | Aug 5, 2005 | SESE |
| K040627 | DEPUY ASR MODULAR ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | Aug 5, 2005 | SESE |
| K050251 | BALANCE HIP SYSTEM | Biomet, Inc. | May 27, 2005 | SESE |
| K043073 | PROCOTYL-E ACETABULAR SYSTEM | Wrightmedicaltechnologyinc | May 4, 2005 | SESE |
| K042530 | CONSERVE PLUS HA ACETABULAR SHELLS | Wrightmedicaltechnologyinc | Dec 17, 2004 | SESE |
| K040354 | METAL/METAL HIP SYSTEM | Encore Medical L.P. | Nov 4, 2004 | SESE |
| K033943 | ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED | Centerpulse Orthopedics, Inc. | Oct 18, 2004 | SESE |
| K042037 | M2A MAGNUM SYSTEM | Biomet, Inc. | Oct 1, 2004 | SESE |
| K033634 | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED | Centerpulse Orthopedics, Inc. | Sep 15, 2004 | SESE |
| K041425 | CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL | Wrightmedicaltechnologyinc | Jun 25, 2004 | SESE |
| K031963 | CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD | Wrightmedicaltechnologyinc | Oct 31, 2003 | SESE |
| K023786 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER | DePuy Orthopaedics, Inc. | Dec 10, 2002 | SESE |
| K021349 | METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) | Wrightmedicaltechnologyinc | Jul 1, 2002 | SESE |
| K011110 | M2A ACETABULAR SYSTEM | Biomet, Inc. | Jul 2, 2001 | SESE |
| K003758 | ALLOFIT ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | Mar 7, 2001 | SESE |
| K003250 | FMP METAL/METAL ACETABULAR INSERT | Encore Orthopedics, Inc. | Jan 25, 2001 | SESE |
| K003523 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | Dec 13, 2000 | SESE |
| K002883 | PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | Oct 13, 2000 | SESE |
| K002379 | M2A 28MM RINGLOC LINER | Biomet, Inc. | Aug 31, 2000 | SESE |
| K001523 | ULTIMA METAL-ON-METAL ACETABULAR CUP | DePuy Orthopaedics, Inc. | Aug 10, 2000 | SESE |
| K001536 | INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS | Sulzer Orthopedics, Inc. | Jul 27, 2000 | SESE |
| K993438 | METAL ON METAL ACETABULAR SYSTEM | Biomet, Inc. | May 18, 2000 | SESE |
| K993569 | APR METASUL ACETABULAR INSERT | Sulzermedica | Dec 1, 1999 | SESE |
| K974728 | INTER-OP METASUL ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | Aug 3, 1999 | SESE |
| K922868 | THOMPSON TYPE HIP PROTHESIS | Osteo Technology, Inc. | Feb 12, 1993 | SESE |
| K902111 | MODIFIED FREEMAN REVISION ACETABULAR CUP | Turnkey Intergration USA, Inc. | Aug 22, 1990 | SESE |
| K902110 | MODIFIED FREEMAN ACETABULAR CUP | Turnkey Intergration USA, Inc. | Aug 22, 1990 | SESE |
| K901626 | H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED | Med-Tek Corp. | Aug 14, 1990 | SESE |
| K895157 | S.A.F. ACETABULAR CUP | Synergy Orthopaedics Intl., Inc. | Dec 1, 1989 | SESE |
| K885049 | RS-CUP ACETABULAR PROSTHESIS | Allo Pro Corp. | Jan 13, 1989 | SESE |
| K882671 | SAMUELSON SCREWLOC CUP | Protek, Inc. | Oct 20, 1988 | SESE |
| K882675 | ATH METAL:UHMWPE TOTAL HIP SYSTEM | Kinamed, Inc. | Aug 19, 1988 | SN |
| K872768 | OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. | Osteonics Corp. | Jan 14, 1988 | SESE |
| K872985 | SAMUELSON ACETABULAR CUP | Protek, Inc. | Oct 1, 1987 | SESE |
| K870924 | CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT. | Protek, Inc. | Sep 14, 1987 | SESE |
| K870923 | SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX. | Protek, Inc. | Sep 14, 1987 | SESE |
| K871453 | ZWEYMUELLER-SL HIP PROSTHESIS STEM | Allo Pro Corp. | Jul 13, 1987 | SESE |
| K871956 | MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT | Downs Surgical , Ltd. | Jun 23, 1987 | SESE |
| K864515 | RING UPM TOTAL HIP REPLACEMENT | Downs Surgical , Ltd. | Mar 13, 1987 | SESE |
| K861723 | (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT | Osteonics Corp. | Jun 9, 1986 | SESE |
| K852699 | FREEMAN ACETABULAR CUP | Advanced Biosearch Assn. | Sep 5, 1985 | SESE |
| K852351 | KIRSCHNER SELF-TAPPING ACETABULAR CUP | Kirschner Medical Corp. | Aug 9, 1985 | SESE |
| K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT | Pfizer, Inc. | Jul 15, 1985 | SESE |
| K851404 | OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES | Osteonics Corp. | Jun 18, 1985 | SESE |
| K843950 | LINK CEMENTLESS SCREW-IN ACETABULAR CUP | Waldemar Link GmbH & Co. KG | Jun 3, 1985 | SESE |
| K843940 | LINK CEMENTLESS SCREW-IN ACETABULAR CUP | Waldemar Link GmbH & Co. KG | Jun 3, 1985 | SESE |
| K851213 | ZWEYMULLER CUP | Allo Pro Corp. | May 28, 1985 | SESE |
| K850773 | PM CEMENTLESS SCREW-IN ACETABULAR CUP | Advanced Biosearch Assn. | May 2, 1985 | SESE |
| K850766 | ZIMMER THREADED ACETABULAR CUP | Zimmer, Inc. | May 1, 1985 | SESE |
| K850055 | PROFILE FEMORAL HIP | Depuy, Inc. | Apr 23, 1985 | SESE |
| K844943 | WEILL CEMENTLESS THREADED ACETABULAR CUP | Advanced Biosearch Assn. | Mar 18, 1985 | SESE |
| K842518 | UNILOC-CEMENTLESS & SELF TAP ACETABULAR | American Ortomed Corp. | Jan 30, 1985 | SESE |
| K842466 | TITANIUM MITTELMEIER TYPE ACETABULAR | American Ortomed Corp. | Jan 30, 1985 | SESE |
| K780330 | TOTAL HIP, LORD MADREPORIC | Howmedica Corp. | May 12, 1978 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 26 clearances
- Biomet Manufacturing Corp — 13 clearances
- DePuy Orthopaedics, Inc. — 12 clearances
- Biomet, Inc. — 11 clearances
- Zimmer GmbH — 5 clearances
