Product code LWJ
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3360
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120595 | UNISYN PLUS HIP STEM | Consensus Orthopedics, Inc. | 2012-10-12 |
| K103518 | TRINITY ACETABULAR SYSTEM | Corin USA | 2011-03-09 |
| K090764 | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | Exactech, Inc. | 2009-04-21 |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | 2008-09-09 |
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | Hayes Medical, Inc. | 2007-01-31 |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | United Orthopedic Corp. | 2007-01-16 |
| K062383 | UNISYN HA PLASMA MODULAR HIP | Hayes Medical, Inc. | 2006-12-21 |
| K061699 | EXCIA | Aesculap, Inc. | 2006-08-18 |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Waldemar Link GmbH & Co. KG | 2005-11-18 |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | 2005-08-15 |
| K042344 | EXCIA TOTAL HIP SYSTEM | Aesculap, Inc. | 2005-03-16 |
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | Osteoimplant Technology, Inc. | 2005-01-25 |
| K033313 | QUATRO M FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | 2004-07-28 |
| K032709 | MODULAR PLUS HIP STEM | Plus Orthopedics | 2003-09-23 |
| K032110 | PROCLASS PRESS FIT HIP STEM | Stelkast Company | 2003-09-22 |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | Plus Orthopedics | 2003-04-24 |
| K023692 | GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER | Howmedica Osteonics Corp. | 2003-03-20 |
| K030122 | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM | DePuy Orthopaedics, Inc. | 2003-02-05 |
| K024134 | UNI HIP STEM | Plus Orthopedics | 2003-01-15 |
| K022966 | PROXILOCK HIP PROSTHESIS; SIZE 12/36 | Implex Corp. | 2002-10-02 |
| K003649 | TRITON HIP SYSTEM | Hayes Medical, Inc. | 2001-02-23 |
| K010243 | TRI-FIT FEMORAL STEM | Corin USA | 2001-02-15 |
| K003016 | PRO-FEMUR R | Wrightmedicaltechnologyinc | 2000-12-13 |
| K994146 | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP | Plus Orthopedics | 2000-12-11 |
| K002941 | ACETABULAR PLATES | Encore Orthopedics, Inc. | 2000-12-04 |
| K002575 | INTER-OP DURASUL ACETABULAR INSERTS (4MM) | Sulzer Orthopedics, Inc. | 2000-11-15 |
| K002796 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | 2000-09-28 |
| K002141 | ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT | Exactech, Inc. | 2000-08-16 |
| K001471 | THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ | Implex Corp. | 2000-08-07 |
| K001745 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | 2000-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07611996074901 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074925 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074932 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074949 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074956 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074970 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074987 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074994 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996075007 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996075014 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996075038 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996081077 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996085471 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081091 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081121 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081138 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081497 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996085341 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996085358 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996085372 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996013788 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081060 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081053 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081039 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081015 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996076394 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996065343 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996045208 | MODULAR-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996014990 | BOFOR/EP-FIT PLUS/PROMOS/MPF | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996013795 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |