510(k) · Cleared

Cleared

Stryker Trauma Plating System

K000636510(k) TraditionalCleared May 11, 200076-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 May 11, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 49 later devices descend from it.

Decided: May 11, 2000
Review: 76 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

49 later devices descend from it, 4 citing it directly.

This deviceK000636 Stryker Trauma Plating SystemHowmedica Osteonics Corp. · 2000
Descendant · cites it directly · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
Descendant · 2 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
Descendant · 3 generations on · 13 of its ownK173135 VariAx 2 SystemStryker GmbH · 2017
Descendant · 4 generations on · 12 of its ownK180500 VariAx 2 SystemStryker GmbH · 2018
Descendant · cites it directly · 11 of its ownK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2004high 6 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 49 · See all

K132502Variax 2 SystemStryker Trauma AG · 2013 · cites it directly21descendants
K140769Variax 2 SystemStryker Trauma AG · 2014 · 2 generations on19descendants
K173135VariAx 2 SystemStryker GmbH · 2017 · 3 generations on13descendants
K180500VariAx 2 SystemStryker GmbH · 2018 · 4 generations on12descendants
K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012 · cites it directly11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000636	Stryker Trauma Plating System	Howmedica Osteonics Corp.	2000	—
+1	K132502	Variax 2 System	Stryker Trauma AG	2013	—
+2	K140769	Variax 2 System	Stryker Trauma AG	2014	—
+3	K173135	VariAx 2 System	Stryker GmbH	2017	—
+4	K180500	VariAx 2 System	Stryker GmbH	2018	—
+1	K120409	Piccolo Composite Plate System	CarboFix Orthopedics, Ltd.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2010	1	0
2011	1	0
2012	2	0
2013	3	0
2014	2	0
2015	4	0
2016	3	0
2017	5	0
2018	3	0
2019	3	0
2020	2	0
2021	2	0
2022	6	0
2023	2	0
2024	4	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K000636, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (49)

See all 49

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

Number	Device	Applicant	Decided	Descendants
K132502	Variax 2 System	Stryker Trauma AG	2013	21
K120409	Piccolo Composite Plate System	CarboFix Orthopedics, Ltd.	2012	11
K072411	Aap Bone Plates and Screw Implants	Aap Implantate AG	2008	9
K040908	Ebi Distal Radius Plating System	Ebi, L.P.	2004	4

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, K132502 (Stryker Trauma AG, 2013) has gone furthest, with 21 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	—

https://510kreport.com/device/K000636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000636: Stryker Trauma Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000636

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026