510(k) · Cleared
ClearedSynthes Ankle Arthrodesis Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Jan 11, 2002 after an 88-day review. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate. 78 later devices descend from it.
- Decided
- Jan 11, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
78 later devices descend from it, 1 citing it directly.
- This deviceK013415 Synthes Ankle Arthrodesis PlateSynthes (Usa) · 2002
- Descendant · cites it directly · 77 of its ownK022255 Modofocation to Synthes Ankle Arthrodesis PlatesSynthes (Usa) · 2002
- Descendant · 2 generations on · 76 of its ownK060473 TTC PlateNew Deal, S.A. · 2006
- Descendant · 2 generations on · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
- Descendant · 2 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K022255Modofocation to Synthes Ankle Arthrodesis PlatesSynthes (Usa) · 2002 · cites it directly77descendants
- K060473TTC PlateNew Deal, S.A. · 2006 · 2 generations on76descendants
- K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · 2 generations on73descendants
- K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 2 generations on69descendants
- K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 3 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013415 | Synthes Ankle Arthrodesis Plate | Synthes (Usa) | 2002 | — |
| +1 | K022255 | Modofocation to Synthes Ankle Arthrodesis Plates | Synthes (Usa) | 2002 | — |
| +2 | K060473 | TTC Plate | New Deal, S.A. | 2006 | — |
| +2 | K073375 | Newdeal Tibiaxys System | Newdeal Sas | 2008 | 2 |
| +2 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| +3 | K100176 | Ascension Ankle Fusion Plate System | Ascension Orthopedics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 2 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 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?
Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate.
What descends from it? (78)
See all 781 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022255 | Modofocation to Synthes Ankle Arthrodesis Plates | 2002 | 77 |
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, K022255 (Synthes (Usa), 2002) has gone furthest, with 77 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle joint and distal tibia.
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/K013415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013415: Synthes Ankle Arthrodesis Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013415
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026