FDA product code KXA: Prosthesis, Hip, Femoral, Resurfacing
KXA is the FDA product code for prosthesis, hip, femoral, resurfacing. It is a Class II device, regulated under 21 CFR 888.3400 and reviewed by the Orthopedic panel. FDA has cleared 23 510(k) submissions under KXA, from 16 different applicants. The average 510(k) review took 93 days (median 79). FDA has posted 16 recalls for KXA devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Femoral, Resurfacing |
| Device class | Class II |
| Regulation | 21 CFR 888.3400 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KXA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 258 |
Compare with all 510(k) review times · Search every KXA clearance
Top KXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corin USA | 2 | 2010-04-15 |
| Wrightmedicaltechnologyinc | 2 | 2008-12-12 |
| Biomet, Inc. | 2 | 2007-06-29 |
| Biopro, Inc. | 2 | 2005-05-18 |
| Biomet Orthopedics, Inc. | 2 | 2002-12-11 |
11 more applicants have KXA clearances. See the full list in Caduvo.
Most recent KXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201219 | Biocore9, LLC | Biocore9 Femoral Head Resurfacing Component | 2021-01-19 | 258 |
| K092198 | Corin USA | CORMET CEMENTLESS RESURFACING FEMORAL HEAD | 2010-04-15 | 268 |
| K082673 | Wrightmedicaltechnologyinc | CONSERVE PRESSFIT FEMORAL COMPONENT | 2008-12-12 | 88 |
| K071053 | Biomet, Inc. | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | 2007-06-29 | 77 |
| K070292 | Zimmer GmbH | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | 2007-04-26 | 85 |
Recalls for KXA devices
16 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-09-04.
Frequently asked questions
What is FDA product code KXA?
KXA is the FDA product code for prosthesis, hip, femoral, resurfacing. It is a Class II device, regulated under 21 CFR 888.3400 and reviewed by the Orthopedic panel.
What device class is KXA?
Class II, regulation 21 CFR 888.3400. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXA?
Across 23 cleared submissions the average was 93 days from receipt to decision (median 79).
Which companies have the most KXA clearances?
Corin USA (2); Wrightmedicaltechnologyinc (2); Biomet, Inc. (2); Biopro, Inc. (2); Biomet Orthopedics, Inc. (2).
Have KXA devices been recalled?
Yes: 16 product recalls across 3 recall events; the most recent began 2012-09-04.
Next steps
- Run an FDA pathway report with predicate devices for product code KXA
- Run a recall and safety report across every KXA manufacturer
- Watch product code KXA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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