510(k) · Cleared
ClearedAxsos 3 TI Locking Plate System Line Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma AG · HWC Screw, Fixation, Bone
Cleared on Dec 18, 2013 as substantially equivalent to K123964 (Stryker Trauma AG, 2013) and 1 other predicate after a 36-day review. Its family tree reaches back 3 generations to 2006. 12 later devices descend from it.
- Decided
- Dec 18, 2013
- Review
- 36 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K061012 (2006). 7 ancestors in all, the oldest K972323 (1997). 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK061012 Axsos Plus Locking Plate SystemHowmedica Osteonics Corp. · 2006 · Recalled
- 2 generations backK122308 Axsos Distal Lateral Femur TS Long PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 1 generation backK123964 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2013
- This deviceK133440 Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG · 2013
- Descendant · cites it directly · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- Descendant · 3 generations on · 5 of its ownK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
- K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 3 generations on7descendants
- K213591ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061012 | Axsos Plus Locking Plate System | Howmedica Osteonics Corp. | 2006 | 2 |
| −2 | K122308 | Axsos Distal Lateral Femur TS Long Plates | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −1 | K123964 | Axsos 3 TI Locking Plate System | Stryker Trauma AG | 2013 | — |
| 0 (this device) | K133440 | Axsos 3 TI Locking Plate System Line Extension | Stryker Trauma AG | 2013 | — |
| +1 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| +3 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| +3 | K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K123964 | Axsos 3 TI Locking Plate SystemSummary page 1…ial 510(k) submission is being supplied to the U.S. FDA to introduce additional screw types and drive features to the currently marketed AxSOS 3 Ti Locking Plate System (K 123964). The additional screw types will include: 3.5mm and 4.5mm Cortex Shaft screws, 4mmn and 6mm Cancellous partially and fully threa… | 2013 |
| * | K972323 | Osteo Bos SystemSummary page 2…teotomies Substantial Equivalency The subject device components are substantially equivalent to the AxSOS 3 Ti Locking Plate System (K123964) and the Osteo BOS System (K972323, currently marketed as the Stryker Plating System) in regards to intended use, design, materials, and operational principles for… | 1997 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173166 | ANTHEM Fracture System | 2017 | 11 |
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 9 months on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K173166 (Globus Medical, Inc., 2017) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K123964.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The AxSOS 3 Ti Locking Plate System Line Extension is intended for long bone fracture fixation.
Indications include:
Diaphyseal, rnetaphyseal, 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/K133440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133440: Axsos 3 TI Locking Plate System Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133440
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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