510(k) · Cleared
ClearedAnkle Arthrodesis Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 27, 2009 as substantially equivalent to K061940 (Synthes (Usa), 2006) and 1 other predicate after a 279-day review. Its family tree reaches back 3 generations to 2002. 54 later devices descend from it.
- Decided
- Oct 27, 2009
- Review
- 279 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K013415 (2002). 5 ancestors in all, the oldest K010321 (2001). 54 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK013415 Synthes Ankle Arthrodesis PlateSynthes (Usa) · 2002
- 2 generations backK022255 Modofocation to Synthes Ankle Arthrodesis PlatesSynthes (Usa) · 2002
- 1 generation backK060473 TTC PlateNew Deal, S.A. · 2006
- This deviceK090139 Ankle Arthrodesis Plate SystemTornier, Inc. · 2009
- Descendant · cites it directly · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 2 generations on · 12 of its ownK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017
- Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · 3 generations on · 9 of its ownK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · cites it directly53descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
- K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017 · 2 generations on12descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
- K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013415 | Synthes Ankle Arthrodesis Plate | Synthes (Usa) | 2002 | — |
| −2 | K022255 | Modofocation to Synthes Ankle Arthrodesis Plates | Synthes (Usa) | 2002 | — |
| −1 | K060473 | TTC Plate | New Deal, S.A. | 2006 | — |
| 0 (this device) | K090139 | Ankle Arthrodesis Plate System | Tornier, Inc. | 2009 | — |
| +1 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
| +2 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +2 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | 2017 | — |
| +3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +3 | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 7 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K061940 | Synthes LCP Ankle Arthrodesis PlatesSummary page 1…Plate: The Anterior Tibio-TalarPlate is substantially equivalent to the Synthes LCP Ankle Arthrodesis Plate, K06 1940. The Lateral Tibio-Talar Plate is substantially equivalent to the Syn… | 2006 |
| * | K060473 | TTC PlateSummary page 1…is substantially equivalent to the Synthes LCP Ankle Arthrodesis Plate, K06 1940, and the Newdeal TTC Plates, K060473. The Lateral Tibio-Talar-CalcanealPlate is substantially equivalent t… | 2006 |
What descends from it? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121425 | Ortholoc 3DI Ankle Fusion Plating System | 2012 | 53 |
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 7 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121425 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 53 descendants of its own.
- 3 other devices also cite its predicate K061940.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Tornier Ankle Arthrodesis Plate System is intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, and fusions of small bones including the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090139: Ankle Arthrodesis Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090139
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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