510(k) · Cleared
Recalled · Class II · 2022Evolve Modular Radial Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Apr 19, 2006 as substantially equivalent to K991915 (Wrightmedicaltechnologyinc, 1999) after a 30-day review. Its family tree reaches back 1 generation to 1999. 7 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 19, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- KWI
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991915 (1999). 7 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK991915 Modular Radial HeadWrightmedicaltechnologyinc · 1999 · Recalled
- This deviceK060731 Evolve Modular Radial HeadWrightmedicaltechnologyinc · 2006
- Descendant · cites it directly · 2 of its ownK183618 Revolution Radial HeadIgnite Orthopedics, Inc. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK192754 Avenger Radial Head SystemIn2bones USA, LLC · 2020
- Descendant · cites it directly · 0 of its ownK260624 Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK233592 BioPoly Radial Head ImplantBioPoly, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK213563 DePuy Synthes Radial Head Replacement SystemDePuy Synthes · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K183618Revolution Radial HeadIgnite Orthopedics, Inc. · 2019 · cites it directly2descendants
- K192754Avenger Radial Head SystemIn2bones USA, LLC · 2020 · cites it directly1descendant
- K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026 · cites it directly0descendants
- K233592BioPoly Radial Head ImplantBioPoly, LLC · 2024 · 2 generations on0descendants
- K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991915 | Modular Radial Head | Wrightmedicaltechnologyinc | 1999 | 3 |
| 0 (this device) | K060731 | Evolve Modular Radial Head | Wrightmedicaltechnologyinc | 2006 | — |
| +1 | K183618 | Revolution Radial Head | Ignite Orthopedics, Inc. | 2019 | 1 |
| +1 | K192754 | Avenger Radial Head System | In2bones USA, LLC | 2020 | — |
| +1 | K260624 | Arthrex Radial Head Replacement System | Arthrex, Inc. | 2026 | — |
| +2 | K233592 | BioPoly Radial Head Implant | BioPoly, LLC | 2024 | — |
| +2 | K213563 | DePuy Synthes Radial Head Replacement System | DePuy Synthes | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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 K260624 Arthrex Radial Head Replacement Systemscore 12.1 · 2 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 |
|---|---|---|---|
| * | K991915 | Modular Radial HeadSummary page 1…s of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k): K991915- EVOLVE® Modular Radial Head. headquarters WrightMedicalTechnology,Inc. 5677 Airline Road Arlington,TN 38002 901.86… | 1999 |
What descends from it? (7)
5 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 |
|---|---|---|---|---|
| Aug 3, 2022 | Class II | Z-0005-2023 | Under Investigation by firm | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. |
| Aug 3, 2022 | Class II | Z-0006-2023 | Under Investigation by firm | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. |
| Aug 26, 2020 | Class II | Z-2989-2020 | Process control | Lack of sterility assurance |
| Dec 27, 2019 | Class II | Z-1102-2020 | Process control | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. |
| Dec 27, 2019 | Class II | Z-1101-2020 | Process control | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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?
Use of the Modular Radial Head Implant may be considered 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060731: Evolve Modular Radial Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060731
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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