510(k) · Cleared
ClearedAxSOS 3 Ti Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma AG · HRS Plate, Fixation, Bone
Cleared on Dec 22, 2014 as substantially equivalent to K041860 (Synthes (Usa), 2004) after a 49-day review. Its family tree reaches back 1 generation to 2004. 26 later devices descend from it.
- Decided
- Dec 22, 2014
- Review
- 49 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041860 (2004). 26 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK041860 Synthes (Usa) LCP Proximal Humerus Plates, LongSynthes (Usa) · 2004
- This deviceK143138 AxSOS 3 Ti Locking Plate SystemStryker Trauma AG · 2014
- Descendant · cites it directly · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
- Descendant · 2 generations on · 24 of its ownK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- Descendant · 2 generations on · 17 of its ownK172350 AxSOS 3 TiStryker GmbH · 2017
- Descendant · 3 generations on · 11 of its ownK181091 AxSOS 3 TiStryker GmbH · 2018
- Descendant · 3 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K153379AxSOS 3TiStryker GmbH · 2016 · cites it directly25descendants
- K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017 · 2 generations on24descendants
- K172350AxSOS 3 TiStryker GmbH · 2017 · 2 generations on17descendants
- K181091AxSOS 3 TiStryker GmbH · 2018 · 3 generations on11descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, Long | Synthes (Usa) | 2004 | — |
| 0 (this device) | K143138 | AxSOS 3 Ti Locking Plate System | Stryker Trauma AG | 2014 | — |
| +1 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| +2 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| +2 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| +3 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| +3 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 4…HWC: Screw, Fixation, Bone PREDICATE DEVICE: Synthes (USA) LCP Proximal Humerus Plates, Long (K041860) No reference devices were used in this submission. DEVICE DESCRIPTION This Traditional… | 2004 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153379 | AxSOS 3Ti | 2016 | 25 |
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. 2014, 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 AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation.
Indications include:
* Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
* Non-unions and malunions
* Normal and osteopenic bone
* Osteotomies
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/K143138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143138: AxSOS 3 Ti Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143138
Report an extraction error
Are you the manufacturer?
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