Epsilon Durasul Constrained Acetabular Liner
FDA 510(k) K030923 · Centerpulse Orthopedics, Inc.
510(k) numberK030923
Submission
- Device name
- Epsilon Durasul Constrained Acetabular Liner
- Applicant
- Centerpulse Orthopedics, Inc.
Austin, TX, US - Received
- March 24, 2003
- Decision date
- October 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3310
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241461 | Mpact Constrained LinerKWZ · Traditional | Medacta International S.A. | 07/31/2025SE |
| K240639 | PINNACLETM Constrained Acetabular LinersKWZ · Special | Depuy Ireland UC | 04/04/2024SE |
| K162641 | Smith & Nephew, Inc. R3 Constrained LinerKWZ · Traditional | Smith & Nephew, Inc. | 06/19/2017SE |
| K163497 | EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal…KWZ · Traditional | Encore Medical L.P. | 03/02/2017SE |
| K161610 | EXPRT Revision Hip SystemKWZ · Traditional | Encore Medical L.P. | 11/09/2016SE |
| K122139 | Smith & Nephew R3 Constrained LinersKWZ · Traditional | Smith & Nephew, Inc. | 10/16/2012SE |
| K111635 | Smith & Nephew RJ Constrained LinersKWZ · Traditional | Smith & Nephew, Inc. | 09/09/2011SE |
| K101730 | Longevity It Highly Crosslinked Polyethylene Constrained LinersKWZ · Traditional | Zimmer, Inc. | 12/03/2010SE |
| K083566 | R3 Constrained Liner, Constrained LinerKWZ · Traditional | Smith & Nephew, Inc. | 03/03/2009SE |
| K072121 | Trabecular Metal Acetabular Revision System Cemented Contrained LinerKWZ · Traditional | Zimmer, Inc. | 01/07/2008SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033943 | Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedKWA · Traditional | 10/18/2004SE |
| 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 |
| 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 Epsilon Durasul Constrained Acetabular Liner cleared by the FDA?
Epsilon Durasul Constrained Acetabular Liner (K030923) received a 510(k) decision of Substantially Equivalent on October 3, 2003, 193 days after the submission was received.
What is the product code of K030923?
The FDA product code is KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3310.