510(k) · Cleared
ClearedAOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Orthopaedic Solutions, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 26, 2020 as substantially equivalent to K052390 (Synthes (Usa), 2005) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Oct 26, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K052390 (2005). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK052390 Synthes LCP Proximal Tibia Plates Line ExtensionSynthes (Usa) · 2005
- This deviceK202489 AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia…Advanced Orthopaedic Solutions, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK261406 Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · 2 generations on · 0 of its ownK262537 Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052390 | Synthes LCP Proximal Tibia Plates Line Extension | Synthes (Usa) | 2005 | — |
| 0 (this device) | K202489 | AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System | Advanced Orthopaedic Solutions, Inc. | 2020 | — |
| +1 | K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +2 | K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K052390 | Synthes LCP Proximal Tibia Plates Line ExtensionSummary page 4…accessories Device Code HRS — Plate, Fixation, Bone Legally Marketed Synthes LCP Proximal Tibia Plate Line Extension (K052390) (Primary) Substantially Equivalent Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates (K0826… | 2005 |
| * | K082624 | Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia PlatesSummary page 4…Proximal Tibia Plate Line Extension (K052390) (Primary) Substantially Equivalent Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates (K082624) Devices Referenced Devices AOS Small Fragment Plating System (K152732) AOS Galileo… | 2008 |
| † | K152732 | AOS Small Fragment Plating System | 2015 |
| † | K021008 | Advanced Orthopaedic Solutions Trochanteric Nail | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261406 | Versalock Proximal Tibial Plating System | 2026 | 1 |
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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 AOS Fibonacci Proximal Tibia Plating System is intended for the fixation of fractures, nonunions, malunions, osteopenic bone, and tibial osteotomies of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
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/K202489 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202489: AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202489
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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