510(k) Report

510(k) · Cleared

Cleared

Talus of Vilex (Tov)

K041289510(k) TraditionalCleared Aug 5, 200484-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, Inc. · HWC Screw, Fixation, Bone

Cleared on Aug 5, 2004 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.

Decided
Aug 5, 2004
Review
84 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

10 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2010: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2011: 2 descendants cleared2013: 1 descendant cleared2022: 1 descendant cleared2016: 1 descendant cleared200020052010201520202025
  1. This deviceK041289 Talus of Vilex (Tov)Vilex, Inc. · 2004
  2. Descendant · cites it directly · 8 of its ownK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
  3. Descendant · 2 generations on · 4 of its ownK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
  5. Descendant · 4 generations on · 2 of its ownK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
  6. Descendant · 2 generations on · 2 of its ownK122738 Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22012: 12013: 12014: 12016: 12017: 22022: 1
2010high 2 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 10 · See all
  • K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies · 2010 · cites it directly8descendants
  • K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 2 generations on4descendants
  • K111834Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 3 generations on3descendants
  • K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 4 generations on2descendants
  • K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041289Talus of Vilex (Tov)Vilex, Inc.2004—
+1K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies2010—
+2K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd.20111
+3K111834Disco Subtalar ImplantTrilliant Surgical, Ltd.20111
+4K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH2013—
+2K122738Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201210
201310
201410
201610
201720
202210
FIG. 1 — Lineage of K041289, 2004–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies20108
K170624TalarLift STSFusion Orthopedics, LLC20170

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, K093820 (Memometal Technologies, 2010) has gone furthest, with 8 descendants of its own.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
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

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Talus of Vilex, as designed, has the following Indications for Use:

Flat foot, pronated subtalar joint.

The material used to manufacture this device is implant-quality titaniumTI6AI4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best removed after the conditions causing the pronation have been corrected. The device is for single use only.

Indications for use as stated in the FDA 510(k) statement.

More from Vilex, Inc.

13 FDA decisions under this applicant name. See the company

  • K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
  • K112837Vilex EZ-Staple (Memory Bone Fixation Staple)Vilex, Inc. · 2012
  • K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 20113 recalls
  • K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
  • K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K041289 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041289: Talus of Vilex (Tov).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041289

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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