FDA Product Code
FDA Product Code KWA — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3330
510(k) Clearances — 114 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122778 | PROFEMUR Z REVISION HIP STEM | Wrightmedicaltechnologyinc | 2012-10-11 | Special | PDF ↗ |
| K121544 | DYNASTY BIOFOAM SHELL | Wrightmedicaltechnologyinc | 2012-07-30 | Traditional | PDF ↗ |
| K113271 | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | Biomet Manufacturing, Inc. | 2012-05-18 | Traditional | PDF ↗ |
| K113322 | CONSERVE THIN SHELL | Wrightmedicaltechnologyinc | 2012-02-03 | Special | PDF ↗ |
| K112080 | PRESERVE HIP STEM | Wrightmedicaltechnologyinc | 2011-12-28 | Special | PDF ↗ |
| K112150 | PROFEMUR GLADIATOR HA HIP STEM | Wrightmedicaltechnologyinc | 2011-11-23 | Traditional | PDF ↗ |
| K113019 | PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER | Wrightmedicaltechnologyinc | 2011-11-10 | Special | PDF ↗ |
| K111910 | GLADIATOR HIP STEM | Wrightmedicaltechnologyinc | 2011-10-14 | Traditional | PDF ↗ |
| K110836 | CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY | Zimmer GmbH | 2011-10-07 | Traditional | PDF ↗ |
| K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | Biomet Manufacturing Corp | 2011-09-30 | Traditional | PDF ↗ |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM | Wrightmedicaltechnologyinc | 2011-08-19 | Special | PDF ↗ |
| K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | Wrightmedicaltechnologyinc | 2011-08-19 | Special | PDF ↗ |
| K110399 | GLADIATOR PLASMA CLASSIC HIP STEM | Wrightmedicaltechnologyinc | 2011-05-10 | Traditional | PDF ↗ |
| K110029 | CONSERVE BIO FOAM SHELL | Wrightmedicaltechnologyinc | 2011-04-19 | Traditional | PDF ↗ |
| K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | Biomet Manufacturing Corp | 2011-01-21 | Special | PDF ↗ |
| K102565 | ANTERIOR APPROACH HIP SURGERY INSTRUMENTS | Wrightmedicaltechnologyinc | 2010-12-22 | Special | PDF ↗ |
| K100469 | ARCOS INTERLOCKING DISTAL STEMS | Biomet Manufacturing Corp | 2010-12-07 | Traditional | PDF ↗ |
| K101086 | TAPERLOC COMPLETE | Biomet, Inc. | 2010-09-03 | Traditional | PDF ↗ |
| K101475 | COMPRESS ANTI-ROTATION SPINDLES | Biomet Manufacturing Corp | 2010-06-18 | Special | PDF ↗ |
| K093235 | RINGLOC + HYBRID ACETABULAR SYSTEM | Biomet, Inc. | 2010-04-30 | Traditional | PDF ↗ |
| K092331 | DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; | Encore Medical L.P. | 2010-03-03 | Traditional | PDF ↗ |
| K091003 | ZIMMER MMC CUP | Zimmer GmbH | 2009-11-24 | Traditional | PDF ↗ |
| K091973 | METASUL TAPER LINERS, METASUL FEMORAL HEADS | Zimmer GmbH | 2009-11-17 | Traditional | PDF ↗ |
| K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | Biomet, Inc. | 2009-09-25 | Traditional | PDF ↗ |
| K091423 | PROFEMUR HIP SYSTEM MODULAR NECKS | Wrightmedicaltechnologyinc | 2009-08-25 | Traditional | PDF ↗ |
| K083651 | REVELATION STEM, MODEL 427-21/42-080/180 | Encore Medical L.P. | 2009-03-13 | Special | PDF ↗ |
| K083642 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | 2009-03-06 | Traditional | PDF ↗ |
| K082924 | DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER | Wrightmedicaltechnologyinc | 2009-03-06 | Special | PDF ↗ |
| K082585 | DEPUY ASPHERE M-SPEC HEAD | DePuy Orthopaedics, Inc. | 2008-12-04 | Special | PDF ↗ |
| K082446 | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS | Biomet, Inc. | 2008-10-15 | Traditional | PDF ↗ |
| K080991 | DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | 2008-07-02 | Traditional | PDF ↗ |
| K081090 | PROFEMUR LX 5/8 COATED HIP STEM | Wrightmedicaltechnologyinc | 2008-05-15 | Special | PDF ↗ |
| K081007 | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM | Zimmer, Inc. | 2008-05-06 | Special | PDF ↗ |
| K080663 | PROFEMUR LX REVISION 5/8 COATED HIP STEM | Wrightmedicaltechnologyinc | 2008-04-08 | Special | PDF ↗ |
| K073637 | PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS | Biomet Manufacturing Corp | 2008-03-20 | Traditional | PDF ↗ |
| K071723 | ZIMMER POROLOCK MIS STEM | Zimmer GmbH | 2008-03-07 | Traditional | PDF ↗ |
| K073413 | DEPUY ASR 300 ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | 2008-01-30 | Special | PDF ↗ |
| K071856 | ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES | Zimmer, Inc. | 2007-07-30 | Special | PDF ↗ |
| K070221 | FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 | Encore Medical L.P. | 2007-04-04 | Traditional | PDF ↗ |
| K070274 | ECHO BI-METRIC PRESS-FIT STEMS | Biomet Manufacturing Corp | 2007-04-03 | Special | PDF ↗ |
| K062994 | LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS | Biomet Manufacturing Corp | 2007-03-09 | Special | PDF ↗ |
| K070359 | DEPUY ASR TAPER SLEEVE ADAPTER | DePuy Orthopaedics, Inc. | 2007-03-06 | Special | PDF ↗ |
| K063614 | ALTRA FX HIP SYSTEM | Biomet Manufacturing Corp | 2007-02-20 | Traditional | PDF ↗ |
| K063251 | ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY | Zimmer, Inc. | 2007-01-24 | Traditional | PDF ↗ |
| K062998 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) | Biomet Manufacturing Corp | 2007-01-19 | Traditional | PDF ↗ |
| K062426 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | 2006-12-15 | Special | PDF ↗ |
| K063414 | MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 | Encore Medical L.P. | 2006-12-12 | Special | PDF ↗ |
| K063002 | ALTRA PRESS-FIT HIP SYSTEM | Biomet Manufacturing Corp | 2006-10-31 | Special | PDF ↗ |
| K062995 | M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT | Biomet Manufacturing Corp | 2006-10-31 | Special | PDF ↗ |
| K061221 | DUPUY S-ROM STD HIP STEM PROSTHESIS | DePuy Orthopaedics, Inc. | 2006-08-28 | Special | PDF ↗ |
| K061423 | M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS | Biomet Manufacturing Corp | 2006-07-27 | Traditional | PDF ↗ |
| K060358 | PROFEMUR TL HIP STEM | Wrightmedicaltechnologyinc | 2006-05-10 | Special | PDF ↗ |
| K060356 | CONSERVE PLUS QUADRAFIX ACETABULAR SHELL | Wrightmedicaltechnologyinc | 2006-04-18 | Special | PDF ↗ |
| K053536 | DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS | Zimmer GmbH | 2006-03-16 | Traditional | PDF ↗ |
| K052915 | PROFEMUR XTR HIP STEM | Wrightmedicaltechnologyinc | 2006-01-27 | Special | PDF ↗ |
| K053588 | PROFEMUR LX HIP STEM | Wrightmedicaltechnologyinc | 2006-01-13 | Special | PDF ↗ |
| K052320 | ENCORE CLP OFFSET TOTAL HIP SYSTEM | Encore Medical Corporation | 2005-12-30 | Traditional | PDF ↗ |
| K052888 | POROUS TITANIUM ACETABULAR AUGMENTS | Biomet Manufacturing Corp | 2005-12-06 | Traditional | PDF ↗ |
| K050124 | POROUS COATED ACETABULAR COMPONENTS | Biomet, Inc. | 2005-10-04 | Traditional | PDF ↗ |
| K043099 | LINEAGE HA ACETABULAR SHELLS | Wrightmedicaltechnologyinc | 2005-09-29 | Traditional | PDF ↗ |
| K043547 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM | Biomet, Inc. | 2005-08-05 | Traditional | PDF ↗ |
| K040627 | DEPUY ASR MODULAR ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | 2005-08-05 | Traditional | PDF ↗ |
| K050251 | BALANCE HIP SYSTEM | Biomet, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K043073 | PROCOTYL-E ACETABULAR SYSTEM | Wrightmedicaltechnologyinc | 2005-05-04 | Traditional | PDF ↗ |
| K042530 | CONSERVE PLUS HA ACETABULAR SHELLS | Wrightmedicaltechnologyinc | 2004-12-17 | Special | PDF ↗ |
| K040354 | METAL/METAL HIP SYSTEM | Encore Medical L.P. | 2004-11-04 | Special | PDF ↗ |
| K033943 | ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED | Centerpulse Orthopedics, Inc. | 2004-10-18 | Traditional | PDF ↗ |
| K042037 | M2A MAGNUM SYSTEM | Biomet, Inc. | 2004-10-01 | Traditional | PDF ↗ |
| K033634 | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED | Centerpulse Orthopedics, Inc. | 2004-09-15 | Traditional | PDF ↗ |
| K041425 | CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL | Wrightmedicaltechnologyinc | 2004-06-25 | Special | PDF ↗ |
| K031963 | CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD | Wrightmedicaltechnologyinc | 2003-10-31 | Special | PDF ↗ |
| K023786 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER | DePuy Orthopaedics, Inc. | 2002-12-10 | Special | PDF ↗ |
| K021349 | METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) | Wrightmedicaltechnologyinc | 2002-07-01 | Abbreviated | PDF ↗ |
| K011110 | M2A ACETABULAR SYSTEM | Biomet, Inc. | 2001-07-02 | Traditional | PDF ↗ |
| K003758 | ALLOFIT ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 2001-03-07 | Traditional | PDF ↗ |
| K003250 | FMP METAL/METAL ACETABULAR INSERT | Encore Orthopedics, Inc. | 2001-01-25 | Traditional | PDF ↗ |
| K003523 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | 2000-12-13 | Special | PDF ↗ |
| K002883 | PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | 2000-10-13 | Special | PDF ↗ |
| K002379 | M2A 28MM RINGLOC LINER | Biomet, Inc. | 2000-08-31 | Special | PDF ↗ |
| K001523 | ULTIMA METAL-ON-METAL ACETABULAR CUP | DePuy Orthopaedics, Inc. | 2000-08-10 | Traditional | PDF ↗ |
| K001536 | INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS | Sulzer Orthopedics, Inc. | 2000-07-27 | Traditional | PDF ↗ |
| K993438 | METAL ON METAL ACETABULAR SYSTEM | Biomet, Inc. | 2000-05-18 | Traditional | PDF ↗ |
| K993569 | APR METASUL ACETABULAR INSERT | Sulzermedica | 1999-12-01 | Special | PDF ↗ |
| K974728 | INTER-OP METASUL ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 1999-08-03 | Traditional | PDF ↗ |
| K922868 | THOMPSON TYPE HIP PROTHESIS | Osteo Technology, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K902111 | MODIFIED FREEMAN REVISION ACETABULAR CUP | Turnkey Intergration USA, Inc. | 1990-08-22 | Traditional | PDF ↗ |
| K902110 | MODIFIED FREEMAN ACETABULAR CUP | Turnkey Intergration USA, Inc. | 1990-08-22 | Traditional | PDF ↗ |
| K901626 | H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED | Med-Tek Corp. | 1990-08-14 | Traditional | PDF ↗ |
| K895157 | S.A.F. ACETABULAR CUP | Synergy Orthopaedics Intl., Inc. | 1989-12-01 | Traditional | PDF ↗ |
| K885049 | RS-CUP ACETABULAR PROSTHESIS | Allo Pro Corp. | 1989-01-13 | Traditional | PDF ↗ |
| K882671 | SAMUELSON SCREWLOC CUP | Protek, Inc. | 1988-10-20 | Traditional | PDF ↗ |
| K882675 | ATH METAL:UHMWPE TOTAL HIP SYSTEM | Kinamed, Inc. | 1988-08-19 | Traditional | PDF ↗ |
| K872768 | OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. | Osteonics Corp. | 1988-01-14 | Traditional | PDF ↗ |
| K872985 | SAMUELSON ACETABULAR CUP | Protek, Inc. | 1987-10-01 | Traditional | PDF ↗ |
| K870924 | CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT. | Protek, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K870923 | SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX. | Protek, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K871453 | ZWEYMUELLER-SL HIP PROSTHESIS STEM | Allo Pro Corp. | 1987-07-13 | Traditional | PDF ↗ |
| K871956 | MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT | Downs Surgical , Ltd. | 1987-06-23 | Traditional | PDF ↗ |
| K864515 | RING UPM TOTAL HIP REPLACEMENT | Downs Surgical , Ltd. | 1987-03-13 | Traditional | PDF ↗ |
| K861723 | (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT | Osteonics Corp. | 1986-06-09 | Traditional | PDF ↗ |
Product code KWA · Class III · Orthopedic. Data: openFDA.