510(k) · Cleared

Cleared

Trident Fusion Implant

K141937510(k) TraditionalCleared Sep 10, 201455-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

Vilex IN Tennessee, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 10, 2014 as substantially equivalent to K111536 (Metasurg, 2011) and 4 other predicates after a 55-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.

Decided: Sep 10, 2014
Review: 55 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K013888 (2002). 13 ancestors in all, the oldest K954330 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
3 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
2 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
1 generation backK111536 Metasurg Digifuse ImplantMetasurg · 2011
This deviceK141937 Trident Fusion ImplantVilex IN Tennessee, Inc. · 2014
Descendant · cites it directly · 0 of its ownK150211 EzFuze Implant SystemVilex IN Tennessee, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all

K150211EzFuze Implant SystemVilex IN Tennessee, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K013888	Fixation (Steinmann) Pins	Miltex, Inc.	2002	—
−3	K031050	PCW Percutaneous Compression Wire	Millennium Medical Technologies, Inc.	2003	—
−2	K062863	Osteomed Extended 2.0/2.4CANNULATED Screw System	Osteomed LP	2006	—
−1	K111536	Metasurg Digifuse Implant	Metasurg	2011	—
0 (this device)	K141937	Trident Fusion Implant	Vilex IN Tennessee, Inc.	2014	—
+1	K150211	EzFuze Implant System	Vilex IN Tennessee, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	2	0
1998	1	0
2001	1	0
2002	1	0
2005	1	0
2010	1	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K141937, 2002–2015Source: 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? (5)

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
*	K111536	Metasurg Digifuse Implant Summary page 4 …cation 21 CFR 888.3040 – Smooth or threaded metallic bone fixation fastener Name: Product Code: HWC/ Orthopedics, Class II K111536 DigiFuse, MetaSurg Predicate Devices: K120645, K101165 Pro-Toe, Wright Medical K022599…	Metasurg	2011	—
*	K120645	Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition Summary page 4 …c bone fixation fastener Name: Product Code: HWC/ Orthopedics, Class II K111536 DigiFuse, MetaSurg Predicate Devices: K120645, K101165 Pro-Toe, Wright Medical K022599 K Wire, Newdeal K052…	Wrightmedicaltechnologyinc	2012	—
*	K101165	Pro-Toe VO Hammertow Implant System Summary page 4 …xation fastener Name: Product Code: HWC/ Orthopedics, Class II K111536 DigiFuse, MetaSurg Predicate Devices: K120645, K101165 Pro-Toe, Wright Medical K022599 K Wire, Newdeal K052736…	Wrightmedicaltechnologyinc	2010	—
*	K022599	Newdeal K Wire Summary page 4 …pedics, Class II K111536 DigiFuse, MetaSurg Predicate Devices: K120645, K101165 Pro-Toe, Wright Medical K022599 K Wire, Newdeal K052736 K-Wire, Arthrex Description of The…	New Deal, S.A.	2002	—
*	K052736	Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT Summary page 4 …e, MetaSurg Predicate Devices: K120645, K101165 Pro-Toe, Wright Medical K022599 K Wire, Newdeal K052736 K-Wire, Arthrex Description of The Vilex Trident Fusion Implant is a single-piece cannulated bone scr…	Arthrex, Inc.	2005	—

Also cleared against K111536: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150211	EzFuze Implant System	Vilex IN Tennessee, Inc.	2015	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?

The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
None of the 13 ancestors has a recall.
Of its descendants, K150211 (Vilex IN Tennessee, Inc., 2015) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K111536.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?

The Trident Fusion Implant has the following Indications for Use:

Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141937 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141937: Trident Fusion Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141937

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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