Oti Alumina Ceramic Femoral Head System
FDA 510(k) K040225 · Osteoimplant Technology, Inc.
510(k) numberK040225
Submission
- Device name
- Oti Alumina Ceramic Femoral Head System
- Applicant
- Osteoimplant Technology, Inc.
Hunt Valley, MD, US - Received
- February 2, 2004
- Decision date
- May 6, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K040685 | Z - Series Modular Total Hip System Plasma CoatedLWJ · Traditional | 01/25/2005SE |
| K041443 | Oti Alumina Ceramic Femoral Head SystemLZO · Special | 11/16/2004SE |
| K032729 | Z-Series Modular Total Hip SystemLPH · Traditional | 12/03/2003SE |
| K030608 | Oti Bone Cement PlugJDK · Traditional | 06/12/2003SESU |
| K022779 | Oti Unicondular Interpositional SpacerHSH · Traditional | 11/20/2002SE |
| K021822 | R120 Modular Total Hip SystemJDI · Traditional | 07/23/2002SE |
| K012762 | MJS Posterior Stabilized Knee SystemHRY · Traditional | 12/11/2001SE |
| K011774 | R120 Modular Total Hip SystemJDI · Traditional | 09/05/2001SE |
| K003316 | Oti Ceramic Femoral Head SystemLZO · Traditional | 01/19/2001SE |
| K003199 | Triad II Modular Total Hip SystemLPH · Traditional | 01/10/2001SE |
Questions and answers
When was Oti Alumina Ceramic Femoral Head System cleared by the FDA?
Oti Alumina Ceramic Femoral Head System (K040225) received a 510(k) decision of Substantially Equivalent on May 6, 2004, 94 days after the submission was received.
What is the product code of K040225?
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.