510(k) Report

510(k) · Cleared

Cleared

Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw

K973309510(k) TraditionalCleared Jan 16, 1998135-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 Jan 16, 1998 after a 135-day review. The FDA summary names no predicate by number. 126 later devices descend from it.

Decided
Jan 16, 1998
Review
135 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

126 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2019: 6 descendants cleared2007: 1 descendant cleared2014: 1 descendant cleared2018: 4 descendants cleared2012: 1 descendant cleared2013: 7 descendants cleared2015: 6 descendants cleared2008: 2 descendants cleared2011: 1 descendant cleared2025: 10 descendants cleared2017: 9 descendants cleared2022: 13 descendants cleared2020: 12 descendants cleared2016: 3 descendants cleared2021: 7 descendants cleared2026: 15 descendants cleared2009: 1 descendant cleared2023: 15 descendants cleared2024: 12 descendants cleared1995200020052010201520202025
  1. This deviceK973309 Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc. · 1998
  2. Descendant · cites it directly · 41 of its ownK124027 Monster Screw SystemApogee Orthosolutions · 2013
  3. Descendant · cites it directly · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
  4. Descendant · cites it directly · 38 of its ownK071092 Asnis Micro Cannulated ScrewHowmedica Osteonics Corp. · 2007
  5. Descendant · 2 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
  6. Descendant · 2 generations on · 27 of its ownK151418 Monster Screw SystemParagon 28 · 2015

Showing 5 of 126 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12011: 12012: 12013: 72014: 12015: 62016: 32017: 92018: 42019: 62020: 122021: 72022: 132023: 152024: 122025: 102026: 15
2007high 15 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 126 · See all
  • K124027Monster Screw SystemApogee Orthosolutions · 2013 · cites it directly41descendants
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · cites it directly39descendants
  • K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp. · 2007 · cites it directly38descendants
  • K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 2 generations on36descendants
  • K151418Monster Screw SystemParagon 28 · 2015 · 2 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973309Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc.1998—
+1K124027Monster Screw SystemApogee Orthosolutions2013—
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.20121
+1K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.2007—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC20132
+2K151418Monster Screw SystemParagon 282015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201110
201210
201370
201410
201560
201630
201790
201840
201960
2020120
202170
2022130
2023150
2024120
2025100
2026150
FIG. 1 — Lineage of K973309, 1998–2026Source: 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 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. #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?

The FDA summary names no predicate by number.

What descends from it? (126)

See all 126

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

NumberDeviceApplicantDecidedDescendants
K124027Monster Screw SystemApogee Orthosolutions201341
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.201239
K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.200738
K133842Tyber Medical Trauma ScrewTyber Medical, LLC201423
K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC20184
K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191

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, K124027 (Apogee Orthosolutions, 2013) has gone furthest, with 41 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 Vilex'DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. [t is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. The material used to manufacture this screw is 316L, implant-quality stainless steel. When properly used with Vilex instrumentation, this screw achieves safe purchase and compression for cortical and cancellous bone fixation in the human body.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K973309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973309: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973309

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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