510(k) · Cleared
ClearedDePuy Synthes Radial Head Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Mar 18, 2022 as substantially equivalent to K183618 (Ignite Orthopedics, Inc., 2019) after a 129-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Mar 18, 2022
- Review
- 129 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991915 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK991915 Modular Radial HeadWrightmedicaltechnologyinc · 1999 · Recalled
- 2 generations backK060731 Evolve Modular Radial HeadWrightmedicaltechnologyinc · 2006 · Recalled
- 1 generation backK183618 Revolution Radial HeadIgnite Orthopedics, Inc. · 2019 · Recalled
- This deviceK213563 DePuy Synthes Radial Head Replacement SystemDePuy Synthes · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991915 | Modular Radial Head | Wrightmedicaltechnologyinc | 1999 | 3 |
| −2 | K060731 | Evolve Modular Radial Head | Wrightmedicaltechnologyinc | 2006 | 5 |
| −1 | K183618 | Revolution Radial Head | Ignite Orthopedics, Inc. | 2019 | 1 |
| 0 (this device) | K213563 | DePuy Synthes Radial Head Replacement System | DePuy Synthes | 2022 | — |
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 |
|---|---|---|---|
| * | K183618 | Revolution Radial HeadSummary page 4…fication Class II Regulation Number: 21 CFR §888.3170 Product Code: KWI Predicate Device Revolution Radial Head - K183618 Device Description This document is regarding the DePuy Synthes Radial Head Replacement System-MR Cond… | 2019 |
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 23 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K183618.
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. 2022, 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?
*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:
o joint destruction and/or subluxation visible on x-ray; and/or
o 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/K213563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213563: DePuy Synthes 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/K213563
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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