510(k) · Cleared

Cleared

Aiming Blocks for Variax Distal Radius Plates

K112455510(k) SpecialCleared Sep 22, 201128-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., Dba Stryker Orthopaedics · HRS Plate, Fixation, Bone

Cleared on Sep 22, 2011 as substantially equivalent to K040022 (Stryker Leibinger, 2004) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1989. 56 later devices descend from it.

Decided: Sep 22, 2011
Review: 28 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K885250 (1989). 13 ancestors in all. 56 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK885250 Alta Tibial/Upper Extremity Metaphyseal Plate SysHowmedica Corp. · 1989
3 generations backK981283 Rogachefsky Distal Radius PlatesHowmedica, Inc. · 1998
2 generations backK040022 Stryker Leibinger Universal Distal Radius SystemStryker Leibinger · 2004
1 generation backK100271 Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010
This deviceK112455 Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011
Descendant · cites it directly · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
Descendant · 2 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
Descendant · 3 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
Descendant · 2 generations on · 16 of its ownK130116 Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013
Descendant · cites it directly · 14 of its ownK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2012high 9 (2024) · low 1 (2012)2026

Most influential descendants

Showing 5 of 56 · See all

K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · cites it directly40descendants
K132502Variax 2 SystemStryker Trauma AG · 2013 · 2 generations on21descendants
K140769Variax 2 SystemStryker Trauma AG · 2014 · 3 generations on19descendants
K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013 · 2 generations on16descendants
K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · cites it directly14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K885250	Alta Tibial/Upper Extremity Metaphyseal Plate Sys	Howmedica Corp.	1989	—
−3	K981283	Rogachefsky Distal Radius Plates	Howmedica, Inc.	1998	—
−2	K040022	Stryker Leibinger Universal Distal Radius System	Stryker Leibinger	2004	—
−1	K100271	Vari AX Distal Radius Line Extensions of XXL Plates	Howmedica Osteonics Corp.	2010	—
0 (this device)	K112455	Aiming Blocks for Variax Distal Radius Plates	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2011	—
+1	K113760	Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2012	—
+2	K132502	Variax 2 System	Stryker Trauma AG	2013	—
+3	K140769	Variax 2 System	Stryker Trauma AG	2014	—
+2	K130116	Superior Lateral Variax Clavicle Plate	Stryker Trauma AG	2013	—
+1	K123562	Flower Small and Medium Bone Implants	Flower Orthopedics Corporation	2013	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	3	0
1998	1	0
2000	1	0
2001	1	0
2002	1	0
2004	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	6	0
2014	4	0
2015	1	0
2016	1	0
2017	5	0
2018	5	0
2019	3	0
2020	2	0
2021	3	0
2022	5	0
2023	4	0
2024	9	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K112455, 1989–2026Source: 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? (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
*	K040022	Stryker Leibinger Universal Distal Radius System Summary page 1 …g System Device Description: This Special 510(k) submission is intended to add aiming blocks as an accessory to the VariAx® Distal Radius plate line which was cleared in K040022 and K100271. The aiming blocks are accessories used intra-operatively to guide the user in placement of the screws into the plate…	Stryker Leibinger	2004	—
*	K100271	Vari AX Distal Radius Line Extensions of XXL Plates Summary page 1 …ice Description: This Special 510(k) submission is intended to add aiming blocks as an accessory to the VariAx® Distal Radius plate line which was cleared in K040022 and K100271. The aiming blocks are accessories used intra-operatively to guide the user in placement of the screws into the plate. There are…	Howmedica Osteonics Corp.	2010	—

Also cleared against K040022: 11 other devices →

What descends from it? (56)

See all 56

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

Number	Device	Applicant	Decided	Descendants
K113760	Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2012	40
K123562	Flower Small and Medium Bone Implants	Flower Orthopedics Corporation	2013	14
K131657	Flower Small and Medium Implant Set	Flower Orthopedics Corporation	2013	11

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 22 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
4 of the 13 ancestors have a recall of any class.
Of its descendants, K113760 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2012) has gone furthest, with 40 descendants of its own.
11 other devices also cite its predicate K040022.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 VariAx®M Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mat-unions. This system can be used for palmar, dorsal or orthogonal application.

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/K112455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112455: Aiming Blocks for Variax Distal Radius Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112455

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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