510(k) · Cleared
ClearedSynthes Pilon Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes · HRS Plate, Fixation, Bone
Cleared on May 20, 2002 after an 87-day review. Our reading found no predicate number; beside “510(k)” the summary reads “000004”, which our checks could not confirm as its predicate. 72 later devices descend from it.
- Decided
- May 20, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
72 later devices descend from it, 4 citing it directly.
- This deviceK020602 Synthes Pilon PlateSynthes · 2002
- Descendant · cites it directly · 55 of its ownK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
- Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
- Descendant · 2 generations on · 15 of its ownK153716 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Gpc Medical, Ltd. · 2016
- Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK193633 APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010 · cites it directly55descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
- K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016 · 2 generations on15descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
- K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020602 | Synthes Pilon Plate | Synthes | 2002 | — |
| +1 | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates | Synthes (Usa) | 2010 | — |
| +2 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
| +2 | K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | Gpc Medical, Ltd. | 2016 | — |
| +3 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K193633 | APTUS® Ankle Trauma System 2.8/3.5 | Medartis AG | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 9 | 0 |
| 2026 | 12 | 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 “000004”, which our checks could not confirm as its predicate.
What descends from it? (72)
See all 724 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, K092812 (Synthes (Usa), 2010) has gone furthest, with 55 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 Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the 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/K020602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020602: Synthes Pilon Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020602
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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