LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class II
FDA Device Classification
Classification Details
- Product Code
- LWJ
- Device Class
- Class II
- Regulation Number
- 888.3360
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K120595 | consensus orthopedics | UNISYN PLUS HIP STEM | October 12, 2012 |
| K103518 | corin usa | TRINITY ACETABULAR SYSTEM | March 9, 2011 |
| K090764 | exactech | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | April 21, 2009 |
| K082146 | aesculap implant systems | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | September 9, 2008 |
| K070061 | hayes medical | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | January 31, 2007 |
| K062978 | united orthopedic | U2 HIP STEM, TI PLASMA SPRAY | January 16, 2007 |
| K062383 | hayes medical | UNISYN HA PLASMA MODULAR HIP | December 21, 2006 |
| K061699 | aesculap | EXCIA | August 18, 2006 |
| K051826 | waldemar link gmbh and co. kg | BETACONE HIP PROSTHESIS SYSTEM | November 18, 2005 |
| K050262 | united orthopedic | U2 ACETABULAR COMPONENT | August 15, 2005 |
| K042344 | aesculap | EXCIA TOTAL HIP SYSTEM | March 16, 2005 |
| K040685 | osteoimplant technology | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | January 25, 2005 |
| K033313 | whiteside biomechanics | QUATRO M FEMORAL COMPONENT | July 28, 2004 |
| K032709 | plus orthopedics | MODULAR PLUS HIP STEM | September 23, 2003 |
| K032110 | stelkast | PROCLASS PRESS FIT HIP STEM | September 22, 2003 |
| K030971 | plus orthopedics | MODIFICATION TO MODULAR PLUS REVISION STEM | April 24, 2003 |
| K023692 | howmedica osteonics | GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER | March 20, 2003 |
| K030122 | depuy orthopaedics | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM | February 5, 2003 |
| K024134 | plus orthopedics | UNI HIP STEM | January 15, 2003 |
| K022966 | implex | PROXILOCK HIP PROSTHESIS; SIZE 12/36 | October 2, 2002 |