LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class II
FDA product code LWJ covers "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented", a Class II medical device regulated under 21 CFR 888.3360. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |