FDA Product Code
FDA Product Code LWJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3360
510(k) Clearances — 81 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K120595 | UNISYN PLUS HIP STEM | Consensus Orthopedics, Inc. | 2012-10-12 | Traditional | PDF ↗ |
| K103518 | TRINITY ACETABULAR SYSTEM | Corin USA | 2011-03-09 | Traditional | PDF ↗ |
| K090764 | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | Exactech, Inc. | 2009-04-21 | Special | PDF ↗ |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | 2008-09-09 | Special | PDF ↗ |
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | Hayes Medical, Inc. | 2007-01-31 | Special | PDF ↗ |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | United Orthopedic Corp. | 2007-01-16 | Traditional | PDF ↗ |
| K062383 | UNISYN HA PLASMA MODULAR HIP | Hayes Medical, Inc. | 2006-12-21 | Special | PDF ↗ |
| K061699 | EXCIA | Aesculap, Inc. | 2006-08-18 | Special | PDF ↗ |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Waldemar Link GmbH & Co. KG | 2005-11-18 | Traditional | PDF ↗ |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | 2005-08-15 | Traditional | PDF ↗ |
| K042344 | EXCIA TOTAL HIP SYSTEM | Aesculap, Inc. | 2005-03-16 | Abbreviated | PDF ↗ |
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | Osteoimplant Technology, Inc. | 2005-01-25 | Traditional | PDF ↗ |
| K033313 | QUATRO M FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | 2004-07-28 | Traditional | PDF ↗ |
| K032709 | MODULAR PLUS HIP STEM | Plus Orthopedics | 2003-09-23 | Special | PDF ↗ |
| K032110 | PROCLASS PRESS FIT HIP STEM | Stelkast Company | 2003-09-22 | Traditional | PDF ↗ |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | Plus Orthopedics | 2003-04-24 | Special | PDF ↗ |
| K023692 | GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER | Howmedica Osteonics Corp. | 2003-03-20 | Traditional | PDF ↗ |
| K030122 | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM | DePuy Orthopaedics, Inc. | 2003-02-05 | Special | PDF ↗ |
| K024134 | UNI HIP STEM | Plus Orthopedics | 2003-01-15 | Special | PDF ↗ |
| K022966 | PROXILOCK HIP PROSTHESIS; SIZE 12/36 | Implex Corp. | 2002-10-02 | Special | PDF ↗ |
| K003649 | TRITON HIP SYSTEM | Hayes Medical, Inc. | 2001-02-23 | Traditional | PDF ↗ |
| K010243 | TRI-FIT FEMORAL STEM | Corin USA | 2001-02-15 | Special | PDF ↗ |
| K003016 | PRO-FEMUR R | Wrightmedicaltechnologyinc | 2000-12-13 | Abbreviated | PDF ↗ |
| K994146 | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP | Plus Orthopedics | 2000-12-11 | Traditional | PDF ↗ |
| K002941 | ACETABULAR PLATES | Encore Orthopedics, Inc. | 2000-12-04 | Traditional | PDF ↗ |
| K002575 | INTER-OP DURASUL ACETABULAR INSERTS (4MM) | Sulzer Orthopedics, Inc. | 2000-11-15 | Traditional | PDF ↗ |
| K002796 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | 2000-09-28 | Special | PDF ↗ |
| K002141 | ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT | Exactech, Inc. | 2000-08-16 | Special | PDF ↗ |
| K001471 | THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ | Implex Corp. | 2000-08-07 | Traditional | PDF ↗ |
| K001745 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | 2000-07-27 | Special | PDF ↗ |
| K001942 | SL-PLUS AND SLR-PLUS STEMS | Plus Orthopedics | 2000-07-25 | Special | PDF ↗ |
| K994126 | MODULAR-PLUS REVISION STEM | Plus Orthopedics | 2000-05-04 | Traditional | PDF ↗ |
| K993601 | HOWMEDICA OSTEONICS FEMORAL HEADS | Howmedica Osteonics Corp. | 1999-11-16 | Special | PDF ↗ |
| K982936 | OSTEONICS EXTENDED FEMORAL BEARING HEAD | Osteonics Corp. | 1998-10-21 | Traditional | PDF ↗ |
| K971900 | LATERAL FLARE INTERNAL COLLAR (LFIC) | Pro-Lfic, LLC | 1997-12-18 | Traditional | PDF ↗ |
| K973077 | PLUS-FIT ACETABULAR CUP | Plus Orthopedics | 1997-11-13 | Traditional | PDF ↗ |
| K972931 | PLUS EPF ACETABULAR CUP | Hhl Consulting | 1997-11-13 | Traditional | PDF ↗ |
| K964178 | PRESS-FIT HIP STEM | Encore Orthopedics, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K955553 | PERFECTA REVISION HIP SYSTEM | Wrightmedicaltechnologyinc | 1996-10-24 | Traditional | PDF ↗ |
| K962268 | CHROME COBALT BALL HEAD | Artos Medical Products GmbH | 1996-10-23 | Traditional | PDF ↗ |
| K962034 | SC, CEMENTLESS HIP SYSTEM | Artos Medical Products GmbH | 1996-10-23 | Traditional | PDF ↗ |
| K961378 | DELTA HIP PROSTHESIS | Zimmer, Inc. | 1996-10-08 | Traditional | PDF ↗ |
| K960633 | PRESS-FIT FLARED SHELL | Encore Orthopedics, Inc. | 1996-10-01 | Traditional | PDF ↗ |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Intermedics Orthopedics | 1996-10-01 | Traditional | PDF ↗ |
| K960908 | SRRS PRESSED FIT FEMORAL REVISION COMPONENT | Stelkast Company | 1996-08-08 | Traditional | PDF ↗ |
| K954854 | INTERMOORE FRACTURE HIP STEM | Intermedics Orthopedics | 1996-02-15 | Traditional | PDF ↗ |
| K952776 | LFIC OR FETTO HIP | Zimmer, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K953268 | DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT | Stelkast Company | 1996-01-17 | Traditional | PDF ↗ |
| K952297 | FOUNDATION TEXTURED STEM | Encore Orthopedics, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K950541 | HOWMEDICA V40 22MM FEMORAL HEAD | Howmedica Corp. | 1995-03-21 | Traditional | PDF ↗ |
| K931423 | PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM | Orthomed | 1994-10-13 | Traditional | PDF ↗ |
| K934909 | COBALT CHROME GEMINI | Depuy, Inc. | 1994-04-28 | Traditional | PDF ↗ |
| K933359 | OSTEONICS 22MM, +10 NECK BEARING HEADS | Osteonics Corp. | 1994-03-07 | Traditional | PDF ↗ |
| K921382 | FUTURA TEXTURE-TRAKKED TOTAL HIP STEM | Arthronics, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K923911 | INTRINSIC STEM | Turnkey Intergration USA, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K910664 | MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. | Medimix Products, Inc. | 1992-04-01 | Traditional | PDF ↗ |
| K913708 | VENUS HIP | Turnkey Intergration USA, Inc. | 1992-01-27 | Traditional | PDF ↗ |
| K914343 | TI-FIT FEMORAL COMPONENT | Smith & Nephew Richards, Inc. | 1992-01-13 | Traditional | PDF ↗ |
| K903563 | HOWMEDICA HNR SYSTEM | Howmedica Corp. | 1991-03-14 | Traditional | PDF ↗ |
| K910010 | Q SYSTEM 28 HIP STEM | Turnkey Intergration USA, Inc. | 1991-03-12 | Traditional | PDF ↗ |
| K905254 | THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH | Depuy, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K905186 | GERI TOTAL HIP SYSTEM | Smith & Nephew Richards, Inc. | 1991-02-15 | Traditional | PDF ↗ |
| K900435 | ACSYS SHEARER ACETABULAR CUP PROSTHESIS | 3M Company | 1990-09-14 | Traditional | PDF ↗ |
| K900262 | ACSYS SELFTAP ACETABULAR CUP PROSTHESIS | 3M Company | 1990-09-14 | Traditional | PDF ↗ |
| K901687 | F-24 FEMORAL HIP PROSTHESIS | Med-Tek Corp. | 1990-09-07 | Traditional | PDF ↗ |
| K901594 | H.N. TOTAL HIP PROSTHESIS | Med-Tek Corp. | 1990-08-03 | Traditional | PDF ↗ |
| K895702 | KDR ACETABULAR COMPONENT | Osteonics Corp. | 1989-11-03 | Traditional | PDF ↗ |
| K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM | Orthopedic Systems, Inc. | 1989-10-13 | Traditional | PDF ↗ |
| K894051 | PREMIER-TOTAL HIP | Intermedics Orthopedics | 1989-08-28 | Traditional | PDF ↗ |
| K893785 | ARC-2F ACETABULAR CUP | Protek, Inc. | 1989-08-09 | Traditional | PDF ↗ |
| K893584 | GRIPPER II ACETABULAR CUP | Joint Medical Products Corp. | 1989-07-28 | Traditional | PDF ↗ |
| K891539 | CTI II STRAIGHT STEM | Orthopedic Systems, Inc. | 1989-06-08 | Traditional | PDF ↗ |
| K891262 | KDG ACETABULAR COMPONENT | Osteonics Corp. | 1989-06-06 | Traditional | PDF ↗ |
| K883794 | RESUBMITTED CLW ACETABULAR CUP W/SULMESH | Protek, Inc. | 1989-05-26 | Traditional | PDF ↗ |
| K883661 | MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) | Depuy, Inc. | 1989-02-08 | Traditional | PDF ↗ |
| K883921 | OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING | Osteonics Corp. | 1988-10-13 | Traditional | PDF ↗ |
| K881983 | HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT | Howmedica Corp. | 1988-10-06 | Traditional | PDF ↗ |
| K881288 | CORIN MODULAR MOORE STEM | Orthopedic Systems, Inc. | 1988-06-29 | Traditional | PDF ↗ |
| K870088 | S-ROM SUPERCUP ACETABULAR CUP | Joint Medical Products Corp. | 1988-04-22 | Traditional | PDF ↗ |
| K873797 | TI-FIT TOTAL HIP SYSTEM | Richards Medical Co., Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K833970 | MICRO-STRUCTURED HS2P HIP STEMS | Osteonics Corp. | 1984-01-27 | Traditional | PDF ↗ |
Product code LWJ · Class II · Orthopedic. Data: openFDA.