510(k) · Cleared
ClearedAvenger Radial Head System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones USA, LLC · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Dec 17, 2021 as substantially equivalent to K192754 (In2bones USA, LLC, 2020) and 2 other predicates after a 99-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 17, 2021
- Review
- 99 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944507 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944507 Metallic Radial Head ImplantsWrightmedicaltechnologyinc · 1995
- 2 generations backK982288 Radial Head ImplantAvanta Orthopaedics, Inc. · 1998 · Recalled
- 1 generation backK192754 Avenger Radial Head SystemIn2bones USA, LLC · 2020
- This deviceK212872 Avenger Radial Head SystemIn2bones USA, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944507 | Metallic Radial Head Implants | Wrightmedicaltechnologyinc | 1995 | — |
| −2 | K982288 | Radial Head Implant | Avanta Orthopaedics, Inc. | 1998 | 1 |
| −1 | K192754 | Avenger Radial Head System | In2bones USA, LLC | 2020 | — |
| 0 (this device) | K212872 | Avenger Radial Head System | In2bones USA, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K192754 | Avenger Radial Head SystemSummary page 5…ial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate • K192754 – In2Bones Avenger Radial Head System Additional Predicates • K991915, K060731 – Wright Medical Evolve® Modular Radial Head… | 2020 |
| * | K991915 | Modular Radial HeadSummary page 5…lly equivalent to the following systems previously cleared by the FDA: Primary Predicate • K192754 – In2Bones Avenger Radial Head System Additional Predicates • K991915, K060731 – Wright Medical Evolve® Modular Radial Head The subject Avenger Radial Head is made of cobalt chrome and has been demo… | 1999 |
| * | K060731 | Evolve Modular Radial HeadSummary page 5…alent to the following systems previously cleared by the FDA: Primary Predicate • K192754 – In2Bones Avenger Radial Head System Additional Predicates • K991915, K060731 – Wright Medical Evolve® Modular Radial Head The subject Avenger Radial Head is made of cobalt chrome and has been demonstrated… | 2006 |
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 26 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
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. 2021, 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 Avenger Radial Head System is intended for replacement of the proximal end of the radius:
* Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-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 components are intended for uncemented use.
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/K212872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212872: Avenger Radial Head System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212872
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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