FDA product code KXE: Prosthesis, Wrist, Hemi-, Ulnar
KXE is the FDA product code for prosthesis, wrist, hemi-, ulnar. It is a Class II device, regulated under 21 CFR 888.3810 and reviewed by the Orthopedic panel. FDA has cleared 16 510(k) submissions under KXE, from 11 different applicants. The average 510(k) review took 114 days (median 76). FDA has posted 3 recalls for KXE devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, Hemi-, Ulnar |
| Device class | Class II |
| Regulation | 21 CFR 888.3810 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KXE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 56 |
Compare with all 510(k) review times · Search every KXE clearance
Top KXE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aptis Medical, LLC | 5 | 2019-05-03 |
| Avanta Orthopaedics, Inc. | 2 | 2001-04-11 |
| Ascension Orthopedic | 1 | 2012-04-09 |
| Remi Sciences, Inc. | 1 | 2008-11-21 |
| Small Bone Innovations, Inc. | 1 | 2006-07-19 |
6 more applicants have KXE clearances. See the full list in Caduvo.
Most recent KXE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190599 | Aptis Medical, LLC | Aptis Medical Distal Radio Ulnar Joint Implant | 2019-05-03 | 56 |
| K142569 | Aptis Medical, LLC | Aptis Medical Distal Radio Ulnar Joint Implant | 2015-04-03 | 203 |
| K112481 | Ascension Orthopedic | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | 2012-04-09 | 224 |
| K081025 | Remi Sciences, Inc. | ISOELASTICU | 2008-11-21 | 225 |
| K082839 | Aptis Medical, LLC | DISTAL RADIO-ULNAR JOINT IMPLANT | 2008-10-24 | 28 |
Recalls for KXE devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-06-24.
Frequently asked questions
What is FDA product code KXE?
KXE is the FDA product code for prosthesis, wrist, hemi-, ulnar. It is a Class II device, regulated under 21 CFR 888.3810 and reviewed by the Orthopedic panel.
What device class is KXE?
Class II, regulation 21 CFR 888.3810. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXE?
Across 16 cleared submissions the average was 114 days from receipt to decision (median 76).
Which companies have the most KXE clearances?
Aptis Medical, LLC (5); Avanta Orthopaedics, Inc. (2); Ascension Orthopedic (1); Remi Sciences, Inc. (1); Small Bone Innovations, Inc. (1).
Have KXE devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2015-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code KXE
- Run a recall and safety report across every KXE manufacturer
- Watch product code KXE 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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