LWJ · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Orthopedic · 21 CFR 888.3360 · Class 2
Overview
| Product Code | LWJ |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Regulation | 21 CFR 888.3360 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 81)
Showing 20 most recent of 81 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120595 | UNISYN PLUS HIP STEM | Consensus Orthopedics, Inc. | Oct 12, 2012 | SESE |
| K103518 | TRINITY ACETABULAR SYSTEM | Corin USA | Mar 9, 2011 | SESE |
| K090764 | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | Exactech, Inc. | Apr 21, 2009 | SESE |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | Sep 9, 2008 | SESE |
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | Hayes Medical, Inc. | Jan 31, 2007 | SESE |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | United Orthopedic Corp. | Jan 16, 2007 | SESE |
| K062383 | UNISYN HA PLASMA MODULAR HIP | Hayes Medical, Inc. | Dec 21, 2006 | SESE |
| K061699 | EXCIA | Aesculap, Inc. | Aug 18, 2006 | SESE |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Waldemar Link GmbH & Co. KG | Nov 18, 2005 | SESE |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | Aug 15, 2005 | SESE |
| K042344 | EXCIA TOTAL HIP SYSTEM | Aesculap, Inc. | Mar 16, 2005 | SESE |
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | Osteoimplant Technology, Inc. | Jan 25, 2005 | SESE |
| K033313 | QUATRO M FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | Jul 28, 2004 | SESE |
| K032709 | MODULAR PLUS HIP STEM | Plus Orthopedics | Sep 23, 2003 | SESE |
| K032110 | PROCLASS PRESS FIT HIP STEM | Stelkast Company | Sep 22, 2003 | SESE |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | Plus Orthopedics | Apr 24, 2003 | SESE |
| K023692 | GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER | Howmedica Osteonics Corp. | Mar 20, 2003 | SESE |
| K030122 | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM | DePuy Orthopaedics, Inc. | Feb 5, 2003 | SESE |
| K024134 | UNI HIP STEM | Plus Orthopedics | Jan 15, 2003 | SESE |
| K022966 | PROXILOCK HIP PROSTHESIS; SIZE 12/36 | Implex Corp. | Oct 2, 2002 | SESE |
Top Applicants
- Plus Orthopedics — 7 clearances
- Osteonics Corp. — 6 clearances
- Stelkast Company — 5 clearances
- Encore Orthopedics, Inc. — 4 clearances
- Turnkey Intergration USA, Inc. — 3 clearances
