510(k) · Cleared

Cleared

Axsos Proximal Lateral Tibia Long Plates

K123403510(k) TraditionalCleared Mar 20, 2013135-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 20, 2013 as substantially equivalent to K061012 (Howmedica Osteonics Corp., 2006) and 1 other predicate after a 135-day review. Its family tree reaches back 1 generation to 2005.

Decided: Mar 20, 2013
Review: 135 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K050512 (2005). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK050512 Stryker Locked Plating SystemHowmedica Osteonics Corp. · 2005
This deviceK123403 Axsos Proximal Lateral Tibia Long PlatesStryker Trauma AG · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K050512	Stryker Locked Plating System	Howmedica Osteonics Corp.	2005	—
0 (this device)	K123403	Axsos Proximal Lateral Tibia Long Plates	Stryker Trauma AG	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K123403, 2005–2013Source: 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

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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	Applicant	Decided	Recalls
*	K061012	Axsos Plus Locking Plate System Summary page 1 …November 2, 2012 Description This Special 5 10O(k) submission is a line extension to address modifications made to the AxSOS Locking Plate System which was cleared in K061012. This line extension is to add tibia long plates to the existing size range of the AxSOS Locking Plate System. These monoaxial lo…	Howmedica Osteonics Corp.	2006	2
*	K050512	Stryker Locked Plating System Summary page 2 …l Lateral Tibia Plates of the AxSOS Locking Plate System cleared under K061012 and to the Proximal Lateral Tibia Plates of the Stryker Plating System (SPS) cleared under K050512 in regards to intended use, design, materials, and operational principles as a bone fixation device. Summary of Non-Clinical Te…	Howmedica Osteonics Corp.	2005	—

Also cleared against K061012: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 2 ancestors has a recall of any class.
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 Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123403: Axsos Proximal Lateral Tibia Long Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123403

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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