510(k) · Cleared
ClearedArthrex Radial Head Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Jul 30, 2026 as substantially equivalent to K060731 (Wrightmedicaltechnologyinc, 2006) after a 154-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jul 30, 2026
- Review
- 154 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991915 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWI device
- #1 K233592 BioPoly Radial Head Implantscore 10.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K060731 | Evolve Modular Radial HeadSummary page 5…uct Code KWI Classification Name 21 CFR 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class II Primary Predicate K060731 – Wright Medical Evolve Modular Radial Device Head Reference Device K181513 – Arthrex PushLock Tenodesis Anchor… | 2006 |
| † | K181513 | Arthrex PushLock Tenodesis Anchor | 2018 |
| † | K041858 | Acumed Anatomic Radial Head System | 2004 |
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 27 years and passes through 2 companies; a new generation was cleared every 20.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 4 other devices also cite its predicate K060731.
How does its category compare?
All KWI devicesKWI Prosthesis, Elbow, Hemi-, Radial, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KWI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KWI
Too few KWI 510(k)s in any year since 2007 to give a median.
Recalls per year · KWI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWI
118in 2025
MAUDE reports naming product code KWI, 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 | 15 |
| 2008 | 0 | — | 0 | 16 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 1 | 31 |
| 2014 | 1 | — | 1 | 29 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 138 |
| 2017 | 1 | — | 1 | 360 |
| 2018 | 0 | — | 0 | 202 |
| 2019 | 1 | — | 0 | 214 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 1 | — | 0 | 44 |
| 2022 | 1 | — | 2 | 44 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 1 | — | 0 | 124 |
| 2025 | 0 | — | 0 | 118 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Arthrex Radial Head Replacement System is indicated for:
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
a) joint destruction and/or subluxation visible on x-ray; and/or
b) resistance to conservative treatment.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.
The Cobalt Chrome stems are intended to be free floating and the Titanium Alloy stems are intended to be press-fit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260624: Arthrex Radial Head Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260624
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026