510(k) · Cleared

Cleared

Stryker Plating System Basic Fragment Set

K012162510(k) TraditionalCleared Aug 31, 200151-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

Howmedica Osteonics Corp. · HRS Plate, Fixation, Bone

Cleared on Aug 31, 2001 after a 51-day review. The FDA summary names no predicate by number. 38 later devices descend from it.

Decided: Aug 31, 2001
Review: 51 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

38 later devices descend from it, 3 citing it directly.

This deviceK012162 Stryker Plating System Basic Fragment SetHowmedica Osteonics Corp. · 2001
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
Descendant · cites it directly · 9 of its ownK072411 Aap Bone Plates and Screw ImplantsAap Implantate AG · 2008

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2002high 4 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 38 · See all

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
K072411Aap Bone Plates and Screw ImplantsAap Implantate AG · 2008 · cites it directly9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012162	Stryker Plating System Basic Fragment Set	Howmedica Osteonics Corp.	2001	—
+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	—
+1	K072411	Aap Bone Plates and Screw Implants	Aap Implantate AG	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	3	0
2006	1	0
2007	2	0
2008	1	0
2012	1	0
2013	2	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2019	1	0
2020	2	0
2021	2	0
2022	2	0
2023	3	0
2024	4	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K012162, 2001–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K123964	Axsos 3 TI Locking Plate System	Stryker Trauma AG	2013	19
K072411	Aap Bone Plates and Screw Implants	Aap Implantate AG	2008	9
K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	7

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?

Of its descendants, K123964 (Stryker Trauma AG, 2013) has gone furthest, with 19 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 Basic Fragment Set is intended for use in long bone fracture fixation.

Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to:

Fractures of the femur

Fractures of the tibia

Fractures of the humerus

Fractures of the pelvis

T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to:

Fractures of the femoral condyles

Fractures of the tibial plateau

Fractures of the distal tibia

Fractures of the proximal-humerus

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/K012162 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012162: Stryker Plating System Basic Fragment Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012162

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026