510(k) · Cleared

Recalled · 2008

Axsos Plus Locking Plate System

K061012510(k) TraditionalCleared May 19, 200637-day reviewClass II21 CFR 888.3030Recalls 2

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

Howmedica Osteonics Corp. · HRS Plate, Fixation, Bone

Cleared on May 19, 2006 after a 37-day review. The FDA summary names its predicate without a number. 28 later devices descend from it. It has been recalled 2 times.

Decided: May 19, 2006
Review: 37 days
Class: Class II
Product code: HRS
Recalls: 2
Predicates: 0

28 later devices descend from it, 8 citing it directly.

This deviceK061012 Axsos Plus Locking Plate SystemHowmedica Osteonics Corp. · 2006
Descendant · cites it directly · 20 of its ownK122308 Axsos Distal Lateral Femur TS Long PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
Descendant · cites it directly · 19 of its ownK123964 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2013
Descendant · 2 generations on · 12 of its ownK133440 Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG · 2013
Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 4 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2009high 4 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 28 · See all

K122308Axsos Distal Lateral Femur TS Long PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · cites it directly20descendants
K123964Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2013 · cites it directly19descendants
K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG · 2013 · 2 generations on12descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 4 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K061012	Axsos Plus Locking Plate System	Howmedica Osteonics Corp.	2006	—
+1	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	—
+2	K133440	Axsos 3 TI Locking Plate System Line Extension	Stryker Trauma AG	2013	—
+3	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—
+4	K180554	ANTHEM Fracture System	Globus Medical, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	3	0
2010	1	0
2011	1	0
2012	1	0
2013	3	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	4	0

FIG. 1 — Lineage of K061012, 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

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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	Applicant	Decided	Recalls
*	—	Stryker® Locked Plating System Named without a submission number			—

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K122308	Axsos Distal Lateral Femur TS Long Plates	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2012	20
K123964	Axsos 3 TI Locking Plate System	Stryker Trauma AG	2013	19
K093868	I.T.S. LRS Locking Reconstruction System	I.T.S. Implantat-Technologie-Systeme GmbH	2010	1
K123403	Axsos Proximal Lateral Tibia Long Plates	Stryker Trauma AG	2013	0
K110476	Axsos (TM) Locking Plate System	Stryker Corp.	2011	0
K092178	Axsos Stryker Locked Plating System Line Extension of Cable Plugs	Howmedica Osteonics Corp.	2009	0
K091619	Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)	Anglefix	2009	0
K092419	Axsos Locked Plating System Line Extension of 3MM Locking Inserts	Howmedica Osteonics Corp.	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 24, 2008	Not classified	Z-1062-2009	Other	Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.
Nov 24, 2008	Not classified	Z-1063-2009	Other	Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K122308 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2012) has gone furthest, with 20 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 AxSOSTM Plus 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/K061012 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061012: Axsos Plus 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/K061012

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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