510(k) · Cleared
ClearedAcumed Anatomic Radial Head System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Oct 5, 2004 as substantially equivalent to K002644 (Avanta Orthopaedics, Inc., 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Oct 5, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991915 (1999). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991915 Modular Radial HeadWrightmedicaltechnologyinc · 1999 · Recalled
- This deviceK041858 Acumed Anatomic Radial Head SystemAcumed, LLC · 2004
- Descendant · cites it directly · 0 of its ownK131845 Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long…Acumed, LLC · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK092721 Align Radial Head SystemSkeletal Dynamics, LLC · 2010 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K041858 | Acumed Anatomic Radial Head System | Acumed, LLC | 2004 | — |
| +1 | K131845 | Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems… | Acumed, LLC | 2013 | 1 |
| +1 | K092721 | Align Radial Head System | Skeletal Dynamics, LLC | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K002644 | Radial Head ImplantSummary page 1…ass: Class 11, 21 CFR 888.3170 Device Product Code: KWI Legally Marketed Equivalent Device(s): Avanta Radial Head Implant K002644 Wright Medical Inc. Modular Radial Head K991915 Device Description: The Acumed Anat… | 2000 |
| * | K991915 | Modular Radial HeadSummary page 1…KWI Legally Marketed Equivalent Device(s): Avanta Radial Head Implant K002644 Wright Medical Inc. Modular Radial Head K991915 Device Description: The Acumed Anatomic Radial Head System includes modular heads and stems with accessories to anatomically rep… | 1999 |
What descends from it? (2)
2 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)
No FDA recall names this device.
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?
The Acumed Anatomic Radial Head System and accessories are designed specifically for:
1. 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: joint destruction and/or subluxation, resistance to conservative treatment.
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection.
4. Revision following failed radial head arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041858: Acumed Anatomic Radial Head System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041858
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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