510(k) · Cleared
ClearedTornier Bipolar Radial Head Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Aug 31, 2000 after a 276-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Aug 31, 2000
- Review
- 276 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK994041 Tornier Bipolar Radial Head ProsthesisTornier, Inc. · 2000
- Descendant · cites it directly · 18 of its ownK060438 RHSTornier · 2006
- Descendant · cites it directly · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
- Descendant · 2 generations on · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
- Descendant · 3 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K060438RHSTornier · 2006 · cites it directly18descendants
- K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · cites it directly16descendants
- K153452Salto XT, Salto TalarisTornier S.A.S. · 2016 · 2 generations on15descendants
- K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · 3 generations on8descendants
- K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994041 | Tornier Bipolar Radial Head Prosthesis | Tornier, Inc. | 2000 | — |
| +1 | K060438 | RHS | Tornier | 2006 | — |
| +1 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
| +2 | K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016 | 8 |
| +3 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| +4 | K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Swanson Radial Head implant, Wright Medical Technologies, Inc. Named without a submission number | |
| * | — | Swanson Titanium Radial Head Implant, Wright Medical Technologies, Inc. Named without a submission number |
What descends from it? (19)
See all 192 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, K060438 (Tornier, 2006) has gone furthest, with 18 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 | — |
What is it indicated for?
Acute traumatic fracture of the proximal radius not suitable for internal fixation.
Unstable elbow following radial head resection, including wrist pain following radial head resection after radio-cubital dislocation or impingement of the carpus.
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/K994041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994041: Tornier Bipolar Radial Head Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994041
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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