510(k) · Cleared

Cleared

Variax Locking Plate System

K060613510(k) TraditionalCleared Apr 21, 200645-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. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Apr 21, 2006 after a 45-day review. The FDA summary names its predicate without a number. 341 later devices descend from it.

Decided: Apr 21, 2006
Review: 45 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

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

This deviceK060613 Variax Locking Plate SystemHowmedica Osteonics Corp. · 2006
Descendant · cites it directly · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
Descendant · 2 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
Descendant · 2 generations on · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
Descendant · 3 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
Descendant · 2 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled

Showing 5 of 341 descendants. See all descendants

Descendants cleared per year

2009high 39 (2024) · low 1 (2009)2026

Most influential descendants

Showing 5 of 341 · See all

K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · cites it directly339descendants
K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 2 generations on228descendants
K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · 2 generations on119descendants
K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 3 generations on118descendants
K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 2 generations on97descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K060613	Variax Locking Plate System	Howmedica Osteonics Corp.	2006	—
+1	K100618	Maxlock Extreme Extremity Plating System with Variable Angle Technology	Orthohelix Surgical Designs, Inc.	2010	—
+2	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—
+2	K102156	Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws	Orthohelix Surgical Designs, Inc.	2010	1
+3	K112583	Synthes Cortical Screws	Synthes (USA) Products, LLC	2011	—
+2	K113014	Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws	Wrightmedicaltechnologyinc	2012	12

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	3	0
2011	2	0
2012	14	0
2013	5	0
2014	13	0
2015	24	0
2016	13	0
2017	29	0
2018	15	0
2019	19	0
2020	27	0
2021	24	0
2022	24	0
2023	28	0
2024	39	0
2025	24	0
2026	37	0

FIG. 1 — Lineage of K060613, 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 KTT? 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 KTT device

#1 K242861 TrueLok Elevatescore 21.3 · 14 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? (3)

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	Recalls
*	—	Numelock II System Named without a submission number	—
*	—	Stryker Locked Plating System Named without a submission number	—
*	—	Stryker Plating System Named without a submission number	—

What descends from it? (341)

See all 341

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

Number	Device	Applicant	Decided	Descendants
K100618	Maxlock Extreme Extremity Plating System with Variable Angle Technology	Orthohelix Surgical Designs, Inc.	2010	339
K131722	I.T.S. Extremity Fixation Systems	I.T.S. GmbH	2013	24
K142418	I.T.S. Hand Locking Plates System - HLS	I.T.S. GmbH	2014	1
K091619	Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)	Anglefix	2009	0

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, K100618 (Orthohelix Surgical Designs, Inc., 2010) has gone furthest, with 339 descendants of its own.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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	9	55	2	45
2008	11	73	1	66
2009	11	94	2	45
2010	12	148	1	121
2011	10	157	0	196
2012	9	140	4	527
2013	7	87	7	898
2014	14	129	0	445
2015	12	60	0	401
2016	10	142	0	400
2017	11	184	1	485
2018	6	149	14	597
2019	8	110	3	800
2020	9	200	0	942
2021	10	83	2	961
2022	3	25	0	627
2023	7	29	0	554
2024	5	90	0	523
2025	10	88	0	673
2026	5	68	11	—

What is it indicated for?

The VariAx Locking Plate System is intended for use in the temporary stabilization

of long bone fractures, including but not limited to:

* Proximal and distal fractures including joint fractures of the humerus, tibia and

other long bones

* Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar

fractures

* Diaphyseal fractures

* Ankle fractures

* Simple, comminuted and depression fractures

* Non-unions and malunions

* Osteotomies and bone reconstruction

* Fractures in normal or osteoporotic bone

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060613: Variax 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/K060613

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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