510(k) · Cleared

Cleared

Axsos 3 TI Locking Plate System

K123964510(k) TraditionalCleared Mar 28, 201392-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Trauma AG · HRS Plate, Fixation, Bone

Cleared on Mar 28, 2013 as substantially equivalent to K061012 (Howmedica Osteonics Corp., 2006) and 5 other predicates after a 92-day review. Its family tree reaches back 2 generations to 2006. 19 later devices descend from it.

Decided: Mar 28, 2013
Review: 92 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K061012 (2006). 6 ancestors in all, the oldest K972323 (1997). 19 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK061012 Axsos Plus Locking Plate SystemHowmedica Osteonics Corp. · 2006 · Recalled
1 generation backK122308 Axsos Distal Lateral Femur TS Long PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
This deviceK123964 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2013
Descendant · cites it directly · 12 of its ownK133440 Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG · 2013
Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
Descendant · 3 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
Descendant · 4 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2013high 4 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 19 · See all

K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG · 2013 · cites it directly12descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants
K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 3 generations on8descendants
K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K061012	Axsos Plus Locking Plate System	Howmedica Osteonics Corp.	2006	2
−1	K122308	Axsos Distal Lateral Femur TS Long Plates	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2012	—
0 (this device)	K123964	Axsos 3 TI Locking Plate System	Stryker Trauma AG	2013	—
+1	K133440	Axsos 3 TI Locking Plate System Line Extension	Stryker Trauma AG	2013	—
+2	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—
+3	K180554	ANTHEM Fracture System	Globus Medical, Inc.	2018	—
+3	K202496	ANTHEM Fracture System	Globus Medical, Inc.	2020	—
+4	K212433	Anthem Fracture System	Globus Medical, Inc.	2021	—

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
2013	1	0
2017	1	0
2018	1	0
2020	1	0
2021	1	0
2022	2	0
2023	2	0
2024	4	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K123964, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K061012	Axsos Plus Locking Plate System Summary page 2 …rison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices: * K061012/K122308 AxSOS Plus Locking Plate System " K062564 Synthes LCP Distal Femur Plates " K052390 Synthes LCP Proximal Tibia…	Howmedica Osteonics Corp.	2006	2
*	K122308	Axsos Distal Lateral Femur TS Long Plates Summary page 2 …owed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices: * K061012/K122308 AxSOS Plus Locking Plate System " K062564 Synthes LCP Distal Femur Plates " K052390 Synthes LCP Proximal Tibia Plates…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2012	—
*	K062564	Synthes LCP Distal Femur Plates Summary page 2 …equivalent in intended, use, materials and performance characteristics to the following predicate devices: * K061012/K122308 AxSOS Plus Locking Plate System " K062564 Synthes LCP Distal Femur Plates " K052390 Synthes LCP Proximal Tibia Plates * K972323 Osteo BOS System " K012162 S…	Synthes (Usa)	2006	—
*	K052390	Synthes LCP Proximal Tibia Plates Line Extension Summary page 2 …ormance characteristics to the following predicate devices: * K061012/K122308 AxSOS Plus Locking Plate System " K062564 Synthes LCP Distal Femur Plates " K052390 Synthes LCP Proximal Tibia Plates * K972323 Osteo BOS System " K012162 Stryker Plating System Basic Fragment Set Non-C…	Synthes (Usa)	2005	—
*	K972323	Osteo Bos System Summary page 2 …e devices: * K061012/K122308 AxSOS Plus Locking Plate System " K062564 Synthes LCP Distal Femur Plates " K052390 Synthes LCP Proximal Tibia Plates * K972323 Osteo BOS System " K012162 Stryker Plating System Basic Fragment Set Non-Clinical Testing Non-clinical laboratory testing w…	Osteonics Corp.	1997	—
*	K012162	Stryker Plating System Basic Fragment Set Summary page 2 …08 AxSOS Plus Locking Plate System " K062564 Synthes LCP Distal Femur Plates " K052390 Synthes LCP Proximal Tibia Plates * K972323 Osteo BOS System " K012162 Stryker Plating System Basic Fragment Set Non-Clinical Testing Non-clinical laboratory testing was performed for the AxSOS 3 Ti…	Howmedica Osteonics Corp.	2001	—

Also cleared against K061012: 7 other devices →

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133440	Axsos 3 TI Locking Plate System Line Extension	Stryker Trauma AG	2013	12
K231262	Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…	Stryker GmbH	2023	4
K220199	AFFINITY Proximal Tibia System	Techfit Digital Surgery, Inc.	2022	0

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 6.4 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K133440 (Stryker Trauma AG, 2013) has gone furthest, with 12 descendants of its own.
7 other devices also cite its predicate K061012.

How does its category compare?

All HRS devices

HRS Plate, 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 · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)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:

Diapyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures

Non-unions and malunions

Normal and osteopenic bone

Osteotomies

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123964: Axsos 3 TI Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123964

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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