Wagner Cone Prosthesis
FDA 510(k) K032380 · Centerpulse Orthopedics, Inc.
510(k) numberK032380
Submission
- Device name
- Wagner Cone Prosthesis
- Applicant
- Centerpulse Orthopedics, Inc.
Austin, TX, US - Received
- August 1, 2003
- Decision date
- September 22, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | Waldemar Link GmbH & Co. KG | 07/06/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | Zimmer, Inc. | 06/16/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | Zimmer, Inc. | 04/27/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | Implantcast GmbH | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | Implantcast GmbH | 03/12/2026SE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | Maxx Orthopedics, Inc. | 01/15/2026SE |
| K250450 | Coated hip implantsLZO · Traditional | Medacta International S.A. | 09/19/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | Signature Orthopaedics Pty, Ltd. | 08/07/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | Zimmer, Inc. | 07/18/2025SE |
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 |
| K030923 | Epsilon Durasul Constrained Acetabular LinerKWZ · Traditional | 10/03/2003SE |
| 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 Wagner Cone Prosthesis cleared by the FDA?
Wagner Cone Prosthesis (K032380) received a 510(k) decision of Substantially Equivalent on September 22, 2003, 52 days after the submission was received.
What is the product code of K032380?
The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.