Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded
FDA 510(k) K033943 · Centerpulse Orthopedics, Inc.
510(k) numberK033943
Submission
- Device name
- Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded
- Applicant
- Centerpulse Orthopedics, Inc.
Austin, TX, US - Received
- December 19, 2003
- Decision date
- October 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3330
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122778 | Profemur Z Revision Hip StemKWA · Special | Wrightmedicaltechnologyinc | 10/11/2012SE |
| K121544 | Dynasty Biofoam ShellKWA · Traditional | Wrightmedicaltechnologyinc | 07/30/2012SE |
| K113271 | Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional | Biomet Manufacturing, Inc. | 05/18/2012SE |
| K113322 | Conserve Thin ShellKWA · Special | Wrightmedicaltechnologyinc | 02/03/2012SE |
| K112080 | Preserve Hip StemKWA · Special | Wrightmedicaltechnologyinc | 12/28/2011SE |
| K112150 | Profemur Gladiator Ha Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 11/23/2011SE |
| K113019 | Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerKWA · Special | Wrightmedicaltechnologyinc | 11/10/2011SE |
| K111910 | Gladiator Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 10/14/2011SE |
| K110836 | CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional | Zimmer GmbH | 10/07/2011SE |
| K110400 | Taperloc Complete Microplasty StemKWA · Traditional | Biomet Manufacturing Corp | 09/30/2011SE |
More from Biomet Manufacturing Corp
| 510(k) | Device | Decision |
|---|---|---|
| K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | 09/15/2004SE |
| K040947 | Durasul BipolarKWY · Traditional | 08/27/2004SE |
| K033810 | Natural-Knee II Unicompartmental Knee SystemHRY · Traditional | 03/05/2004SE |
| K033664 | Modification to Alloclassic Zweymuller SL Offset Femoral StemLZO · Special | 12/17/2003SE |
| K032348 | Converge Reti-Lock Multi-Hole Reinforcement CupLZO · Traditional | 10/24/2003SE |
| K030923 | Epsilon Durasul Constrained Acetabular LinerKWZ · Traditional | 10/03/2003SE |
| K032380 | Wagner Cone ProsthesisLZO · Traditional | 09/22/2003SE |
| K031183 | Tibial Spacer for the Natural-Knee II Cemented Modular Tibial BaseplateJWH · Traditional | 07/14/2003SE |
| K030373 | Alloclassic Zweymueller Sl/Sll Femoral StemLZO · Special | 03/06/2003SE |
Questions and answers
When was Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded cleared by the FDA?
Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded (K033943) received a 510(k) decision of Substantially Equivalent on October 18, 2004, 304 days after the submission was received.
What is the product code of K033943?
The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.