KWA · Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Orthopedic · 21 CFR 888.3330 · Class 3
Overview
| Product Code | KWA |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
| Regulation | 21 CFR 888.3330 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).
Classification Rationale
Class III.
Recent Cleared Devices (20 of 114)
Showing 20 most recent of 114 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122778 | PROFEMUR Z REVISION HIP STEM | Wrightmedicaltechnologyinc | Oct 11, 2012 | SESE |
| K121544 | DYNASTY BIOFOAM SHELL | Wrightmedicaltechnologyinc | Jul 30, 2012 | SESE |
| K113271 | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | Biomet Manufacturing, Inc. | May 18, 2012 | SESE |
| K113322 | CONSERVE THIN SHELL | Wrightmedicaltechnologyinc | Feb 3, 2012 | SESE |
| K112080 | PRESERVE HIP STEM | Wrightmedicaltechnologyinc | Dec 28, 2011 | SESE |
| K112150 | PROFEMUR GLADIATOR HA HIP STEM | Wrightmedicaltechnologyinc | Nov 23, 2011 | SESE |
| K113019 | PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER | Wrightmedicaltechnologyinc | Nov 10, 2011 | SESE |
| K111910 | GLADIATOR HIP STEM | Wrightmedicaltechnologyinc | Oct 14, 2011 | SESE |
| K110836 | CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY | Zimmer GmbH | Oct 7, 2011 | SESE |
| K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | Biomet Manufacturing Corp | Sep 30, 2011 | SESE |
| K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | Wrightmedicaltechnologyinc | Aug 19, 2011 | SESE |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM | Wrightmedicaltechnologyinc | Aug 19, 2011 | SESE |
| K110399 | GLADIATOR PLASMA CLASSIC HIP STEM | Wrightmedicaltechnologyinc | May 10, 2011 | SESE |
| K110029 | CONSERVE BIO FOAM SHELL | Wrightmedicaltechnologyinc | Apr 19, 2011 | SESE |
| K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | Biomet Manufacturing Corp | Jan 21, 2011 | SESE |
| K102565 | ANTERIOR APPROACH HIP SURGERY INSTRUMENTS | Wrightmedicaltechnologyinc | Dec 22, 2010 | SESE |
| K100469 | ARCOS INTERLOCKING DISTAL STEMS | Biomet Manufacturing Corp | Dec 7, 2010 | SESE |
| K101086 | TAPERLOC COMPLETE | Biomet, Inc. | Sep 3, 2010 | SESE |
| K101475 | COMPRESS ANTI-ROTATION SPINDLES | Biomet Manufacturing Corp | Jun 18, 2010 | SESE |
| K093235 | RINGLOC + HYBRID ACETABULAR SYSTEM | Biomet, Inc. | Apr 30, 2010 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 26 clearances
- Biomet Manufacturing Corp — 13 clearances
- DePuy Orthopaedics, Inc. — 12 clearances
- Biomet, Inc. — 11 clearances
- Zimmer GmbH — 5 clearances
