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 Dec 7, 2005 after a 30-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Dec 7, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- KXE
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK053119 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 · 2 generations on · 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) | K053119 | Distal Radio-Ulnar Joint Implant | Aptis Medical, LLC | 2005 | — |
| +1 | K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2015 | — |
| +2 | 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 |
|---|---|---|---|
| * | — | Aptis Medical Distal Radio-Ulnar Joint Implant Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | 2015 | 1 |
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/K053119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053119: Distal Radio-Ulnar Joint Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053119
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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