510(k) · Cleared
Recalled · Class II · 2013Ulnar Head Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanta Orthopaedics, Inc. · KXE Prosthesis, Wrist, Hemi-, Ulnar
Cleared on Apr 11, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 11, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- KXE
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK010786 Ulnar Head ImplantAvanta Orthopaedics, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK052137 Ascension MuhAscension Orthopedics, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK112481 First Choice Druj System, Partial Head ImplantAscension Orthopedic · 2012
- Descendant · cites it directly · 0 of its ownK061146 Sbi Ulnar Head ImplantSmall Bone Innovations, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK042902 Herbert Ulnar Head Prosthesis SystemStuckenbrock Medizintechnik GmbH · 2004
- Descendant · cites it directly · 0 of its ownK020274 WMT Modular Ulnar Head ImplantWrightmedicaltechnologyinc · 2002
Most influential descendants
Showing 5 of 5 · See all- K052137Ascension MuhAscension Orthopedics, Inc. · 2005 · cites it directly1descendant
- K112481First Choice Druj System, Partial Head ImplantAscension Orthopedic · 2012 · 2 generations on0descendants
- K061146Sbi Ulnar Head ImplantSmall Bone Innovations, Inc. · 2006 · cites it directly0descendants
- K042902Herbert Ulnar Head Prosthesis SystemStuckenbrock Medizintechnik GmbH · 2004 · cites it directly0descendants
- K020274WMT Modular Ulnar Head ImplantWrightmedicaltechnologyinc · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010786 | Ulnar Head Implant | Avanta Orthopaedics, Inc. | 2001 | — |
| +1 | K052137 | Ascension Muh | Ascension Orthopedics, Inc. | 2005 | — |
| +2 | K112481 | First Choice Druj System, Partial Head Implant | Ascension Orthopedic | 2012 | — |
| +1 | K061146 | Sbi Ulnar Head Implant | Small Bone Innovations, Inc. | 2006 | 2 |
| +1 | K042902 | Herbert Ulnar Head Prosthesis System | Stuckenbrock Medizintechnik GmbH | 2004 | — |
| +1 | K020274 | WMT Modular Ulnar Head Implant | Wrightmedicaltechnologyinc | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2013 | Class II | Z-0098-2014 | Packaging change control | The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052137 (Ascension Orthopedics, Inc., 2005) 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 | — |
https://510kreport.com/device/K010786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010786: 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/K010786
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026