Depuy Asr Resurfacing Femoral Heads
FDA 510(k) K032659 · DePuy Orthopaedics, Inc.
510(k) numberK032659
Submission
- Device name
- Depuy Asr Resurfacing Femoral Heads
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- August 28, 2003
- Decision date
- December 4, 2003
- 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 |
| K070292 | Durom Hip Resurfacing System, Femoral ComponentsKXA · Traditional | Zimmer GmbH | 04/26/2007SE |
| K062960 | Conserve Femoral Resurfacing ComponentKXA · Special | Wrightmedicaltechnologyinc | 12/01/2006SE |
| K043542 | Biopro Tara Femoral Resurfacing ComponentKXA · Traditional | Biopro, Inc. | 05/18/2005SE |
| 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 |
|---|---|---|
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | 09/04/2026SE |
| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | 05/22/2026SE |
| K231503 | CUPTIMIZE AdvancedLLZ · Traditional | 08/22/2023SE |
| K213839 | DePuy Corail AMT Hip ProsthesisLZO · Special | 01/06/2022SE |
| K210167 | DELTA XTEND Reverse Shoulder SystemPHX · Special | 02/19/2021SE |
| K203167 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/19/2020SE |
| K202472 | ACTIS Duofix Hip ProsthesisLPH · Special | 10/21/2020SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | 06/18/2020SE |
| K193540 | TRUMATCH Personalized SolutionsJWH · Traditional | 06/16/2020SE |
| K193398 | Summit DuoFix HA CoatingMEH · Special | 02/04/2020SE |
Questions and answers
When was Depuy Asr Resurfacing Femoral Heads cleared by the FDA?
Depuy Asr Resurfacing Femoral Heads (K032659) received a 510(k) decision of Substantially Equivalent on December 4, 2003, 98 days after the submission was received.
What is the product code of K032659?
The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.