510(k) · Cleared

Cleared

ToeMATE® Hammertoe Correction System

K170350510(k) SpecialCleared Mar 3, 201728-day reviewClass II21 CFR 888.3040

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

Arthrosurface, Inc. · HWC Screw, Fixation, Bone

Cleared on Mar 3, 2017 as substantially equivalent to K130859 (Arthrosurface, Inc., 2013) and 2 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1996.

Decided: Mar 3, 2017
Review: 28 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K960385 (1996). 11 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
4 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
3 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
2 generations backK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
1 generation backK130859 Hammertoe Correction SystemArthrosurface, Inc. · 2013
This deviceK170350 ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K960385	Sterile Kirschner Wires and Steinmann Pins	Depuy, Inc.	1996	—
−4	K022599	Newdeal K Wire	New Deal, S.A.	2002	—
−3	K070598	Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse	Memometal Technologies	2007	—
−2	K110445	Flexfusion (TM) Fixation Implant	Nextremity Solutions, LLC	2011	6
−1	K130859	Hammertoe Correction System	Arthrosurface, Inc.	2013	—
0 (this device)	K170350	ToeMATE® Hammertoe Correction System	Arthrosurface, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2005	1	0
2010	1	0
2012	1	0

FIG. 1 — Lineage of K170350, 1996–2017Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 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	Applicant	Decided	Recalls
*	K130859	Hammertoe Correction System Summary page 5 …ly equivalent in indications and design principles to the following predicate and/or reference devices, which have been previously cleared by the FDA: Primary Predicate K130859 Arthrosurface, Inc.’s Hammertoe Correction System Additional Predicate(s) K101165 Wright Medical PRO-TOE™ V…	Arthrosurface, Inc.	2013	—
*	K101165	Pro-Toe VO Hammertow Implant System Summary page 5 …rence devices, which have been previously cleared by the FDA: Primary Predicate K130859 Arthrosurface, Inc.’s Hammertoe Correction System Additional Predicate(s) K101165 Wright Medical PRO-TOE™ VO Hammertoe Implant System K120645 The fundamental scientific technology of the proposed…	Wrightmedicaltechnologyinc	2010	—
*	K120645	Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition Summary page 5 …icate K130859 Arthrosurface, Inc.’s Hammertoe Correction System Additional Predicate(s) K101165 Wright Medical PRO-TOE™ VO Hammertoe Implant System K120645 The fundamental scientific technology of the proposed device has not changed relative to the predicate devices. • Has the same I…	Wrightmedicaltechnologyinc	2012	—

Also cleared against K130859: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
2 of the 11 ancestors have a recall of any class.
3 other devices also cite its predicate K130859.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170350 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170350: ToeMATE® Hammertoe Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170350

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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