510(k) · Cleared
ClearedWMT Modular Ulnar Head Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KXE Prosthesis, Wrist, Hemi-, Ulnar
Cleared on Feb 22, 2002 as substantially equivalent to K010786 (Avanta Orthopaedics, Inc., 2001) after a 25-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Feb 22, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- KXE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010786 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010786 Ulnar Head ImplantAvanta Orthopaedics, Inc. · 2001 · Recalled
- This deviceK020274 WMT Modular Ulnar Head ImplantWrightmedicaltechnologyinc · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010786 | Ulnar Head Implant | Avanta Orthopaedics, Inc. | 2001 | 1 |
| 0 (this device) | K020274 | WMT Modular Ulnar Head Implant | Wrightmedicaltechnologyinc | 2002 | — |
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 |
|---|---|---|---|
| * | K010786 | Ulnar Head ImplantSummary page 2…mplant (Figure 1) is substantially equivalent to the Avanta uHead™ modular ulnar head implant (previously submitted and cleared under AVANTA ULNAR HEAD IMPLANT - 510(k): K010786). Figure 1 - 'Comparison Between WMT and Avanta uHead™ modular ulnar head implants Wright Medical Technology AVANTA Standard S… | 2001 |
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K010786.
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?
The WMT Modular Ulnar Head Implant is indicated for the following indications:
Replacement of the distal ulnar head for disorders of the distal radioulnar joint in rheumatoid, degenerative and post-traumatic arthritis presenting with the following findings:
-pain and weakness of the wrist joint not improved by nonoperative treatment;
-instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020274: WMT Modular Ulnar Head Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020274
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