510(k) · Cleared
ClearedMetallic Radial Head Implants
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 Jul 13, 1995 after a 301-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.
- Decided
- Jul 13, 1995
- Review
- 301 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 3 citing it directly.
- This deviceK944507 Metallic Radial Head ImplantsWrightmedicaltechnologyinc · 1995
- Descendant · cites it directly · 27 of its ownK982288 Radial Head ImplantAvanta Orthopaedics, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 19 of its ownK023604 Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 18 of its ownK060438 RHSTornier · 2006
- Descendant · 3 generations on · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
- Descendant · 4 generations on · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K982288Radial Head ImplantAvanta Orthopaedics, Inc. · 1998 · cites it directly27descendants
- K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 2002 · 2 generations on19descendants
- K060438RHSTornier · 2006 · 3 generations on18descendants
- K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · 3 generations on16descendants
- K153452Salto XT, Salto TalarisTornier S.A.S. · 2016 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944507 | Metallic Radial Head Implants | Wrightmedicaltechnologyinc | 1995 | — |
| +1 | K982288 | Radial Head Implant | Avanta Orthopaedics, Inc. | 1998 | 1 |
| +2 | K023604 | Modification to Radial Head Implant | Avanta Orthopaedics, Inc. | 2002 | 18 |
| +3 | K060438 | RHS | Tornier | 2006 | — |
| +3 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
| +4 | K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (28)
See all 283 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?
- Of its descendants, K982288 (Avanta Orthopaedics, Inc., 1998) has gone furthest, with 27 descendants of its own.
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 | — |
https://510kreport.com/device/K944507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944507: Metallic Radial Head Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944507
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026