510(k) · Cleared
ClearedAptis Medical Distal 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 May 3, 2019 as substantially equivalent to K142569 (Aptis Medical, LLC, 2015) and 2 other predicates after a 56-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- May 3, 2019
- Review
- 56 days
- Class
- Class II
- Product code
- KXE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K040497 (2005). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040497 | Distal Radio-Ulnar Joint Implant | Aptis Medical, LLC | 2005 | — |
| −1 | K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2015 | — |
| 0 (this device) | K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K142569 | Aptis Medical Distal Radio Ulnar Joint ImplantSummary page 4…7 KXE III. Predicate Device Predicate Device: Aptis Medical Distal Radio Ulnar Joint Implant Primary predicate: K142569 Additional predicates: K082839, K040497 IV. Device Description The Aptis Medical Dista… | 2015 |
| * | K082839 | Distal Radio-Ulnar Joint ImplantSummary page 4…Aptis Medical Distal Radio Ulnar Joint Implant Primary predicate: K142569 Additional predicates: K082839, K040497 IV. Device Description The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device inc… | 2008 |
| * | K040497 | Distal Radio-Ulnar Joint ImplantSummary page 4…s Medical Distal Radio Ulnar Joint Implant Primary predicate: K142569 Additional predicates: K082839, K040497 IV. Device Description The Aptis Medical Distal Radio Ulnar Joint Implant system, like the predicate device includes var… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 10.2 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KXE devicesKXE Prosthesis, Wrist, Hemi-, Ulnar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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?
The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar 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…
Read the full statement (107 words)
The Aptis Medical Distal Radio Ulnar Joint Implant is intended for replacement of the distal radio ulnar 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 radio ulnar joint
● Failed ulnar head resection; e.g. Darrach resection
● Primary replacement after fracture of the ulnar head or neck.
● Revision following failed ulnar head arthroplasty.
This prosthesis is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190599 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190599: Aptis Medical Distal Radio Ulnar Joint Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190599
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