Durom Hip Resurfacing System, Femoral Components
FDA 510(k) K070292 · Zimmer GmbH
510(k) numberK070292
Submission
- Device name
- Durom Hip Resurfacing System, Femoral Components
- Applicant
- Zimmer GmbH
Warsaw, IN, US - Received
- January 31, 2007
- Decision date
- April 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KXA – Prosthesis, Hip, Femoral, Resurfacing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3400
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KXA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201219 | Biocore9 Femoral Head Resurfacing ComponentKXA · Traditional | Biocore9, LLC | 01/19/2021SE |
| K092198 | Cormet Cementless Resurfacing Femoral HeadKXA · Traditional | Corin USA | 04/15/2010SE |
| K082673 | Conserve Pressfit Femoral ComponentKXA · Traditional | Wrightmedicaltechnologyinc | 12/12/2008SE |
| K071053 | Recap Ha Press-Fit Femoral Resurfacing HeadKXA · Special | Biomet, Inc. | 06/29/2007SE |
| K062960 | Conserve Femoral Resurfacing ComponentKXA · Special | Wrightmedicaltechnologyinc | 12/01/2006SE |
| K043542 | Biopro Tara Femoral Resurfacing ComponentKXA · Traditional | Biopro, Inc. | 05/18/2005SE |
| K032659 | Depuy Asr Resurfacing Femoral HeadsKXA · Traditional | DePuy Orthopaedics, Inc. | 12/04/2003SE |
| K023188 | Press-Fit Head Resurfacing DeviceKXA · Traditional | Biomet Orthopedics, Inc. | 12/11/2002SE |
| K021549 | Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemKXA · Traditional | Std Mfg., Inc. | 08/01/2002SE |
| K021799 | Cemented Femoral Head Resurfing DeviceKXA · Special | Biomet Orthopedics, Inc. | 06/26/2002SE |
More from Biomet Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | 06/16/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | 06/16/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | 05/28/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | 04/27/2026SE |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | 04/13/2026SE |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | 03/12/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | 03/09/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | 02/04/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | 08/11/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | 07/18/2025SE |
Questions and answers
When was Durom Hip Resurfacing System, Femoral Components cleared by the FDA?
Durom Hip Resurfacing System, Femoral Components (K070292) received a 510(k) decision of Substantially Equivalent on April 26, 2007, 85 days after the submission was received.
What is the product code of K070292?
The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.