Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System
FDA 510(k) K021549 · Std Mfg., Inc.
510(k) numberK021549
Submission
- Device name
- Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System
- Applicant
- Std Mfg., Inc.
Stoughton, MA, US - Received
- May 13, 2002
- Decision date
- August 1, 2002
- 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 |
| 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 |
| K021799 | Cemented Femoral Head Resurfing DeviceKXA · Special | Biomet Orthopedics, Inc. | 06/26/2002SE |
More from Biomet Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023096 | Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemHSD · Traditional | 04/10/2003SE |
| K012362 | Modification to Vascular Closure DeviceGDW · Special | 08/23/2001SE |
| K003169 | Vascular Closure DeviceGDW · Traditional | 12/08/2000SE |
| K000608 | Suction Vascular Stapler and Implantable Staple SystemGDW · Traditional | 03/07/2000SE |
| K930427 | STD Irrigation PumpGCJ · Traditional | 06/01/1993SE |
Questions and answers
When was Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System cleared by the FDA?
Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing System (K021549) received a 510(k) decision of Substantially Equivalent on August 1, 2002, 80 days after the submission was received.
What is the product code of K021549?
The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.