510(k) · Cleared
ClearedDistal Radio-Ulnar Joint Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aptis Medical, LLC · KXE Prosthesis, Wrist, Hemi-, Ulnar
Cleared on Jan 26, 2005 after a 335-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jan 26, 2005
- Review
- 335 days
- Class
- Class II
- Product code
- KXE
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK040497 Distal Radio-Ulnar Joint ImplantAptis Medical, LLC · 2005
- Descendant · cites it directly · 1 of its ownK142569 Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLC · 2015
- Descendant · cites it directly · 0 of its ownK190599 Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040497 | Distal Radio-Ulnar Joint Implant | Aptis Medical, LLC | 2005 | — |
| +1 | K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2015 | — |
| +1 | K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | WMT Modular Ulnar Head Implant Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142569 (Aptis Medical, LLC, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KXE devicesKXE Prosthesis, Wrist, Hemi-, Ulnar: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KXE
Too few KXE 510(k)s in any year since 2007 to give a median.
Recalls per year · KXE
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXE
1in 2023
MAUDE reports naming product code KXE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
* Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:
* Pain and weakness of the wrist joint not improved by non-operative treatment
* Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint
* Failed ulnar head resection; eg. Darrach resection
* Primary replacement after fracture of the ulnar head or neck.
* Revision following failed ulnar head arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040497 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040497: Distal Radio-Ulnar Joint Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040497
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026