510(k) Report

510(k) · Cleared

Cleared

Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24

K991197510(k) TraditionalCleared Apr 26, 199919-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 Apr 26, 1999 after a 19-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 114 later devices descend from it.

Decided
Apr 26, 1999
Review
19 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

114 later devices descend from it, 14 citing it directly.

Descendants, by year cleared 2015: 5 descendants cleared2010: 1 descendant cleared2007: 3 descendants cleared2018: 5 descendants cleared2017: 8 descendants cleared2009: 2 descendants cleared2019: 5 descendants cleared2006: 1 descendant cleared2012: 1 descendant cleared2025: 10 descendants cleared2013: 7 descendants cleared2023: 14 descendants cleared2014: 2 descendants cleared2008: 2 descendants cleared2011: 1 descendant cleared2022: 11 descendants cleared2020: 11 descendants cleared2026: 10 descendants cleared2016: 1 descendant cleared2021: 6 descendants cleared2024: 8 descendants cleared1995200020052010201520202025
  1. This deviceK991197 Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX…Vilex, Inc. · 1999
  2. Descendant · cites it directly · 41 of its ownK124027 Monster Screw SystemApogee Orthosolutions · 2013
  3. Descendant · cites it directly · 40 of its ownK101030 Modification to HBS Headless Bone ScrewBiopro, Inc. · 2010 · Recalled
  4. Descendant · cites it directly · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
  5. Descendant · cites it directly · 38 of its ownK071092 Asnis Micro Cannulated ScrewHowmedica Osteonics Corp. · 2007
  6. Descendant · 2 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled

Showing 5 of 114 descendants. See all descendants

Descendants cleared per year

2006: 12007: 32008: 22009: 22010: 12011: 12012: 12013: 72014: 22015: 52016: 12017: 82018: 52019: 52020: 112021: 62022: 112023: 142024: 82025: 102026: 10
2006high 14 (2023) · low 1 (2006)2026

Most influential descendants

Showing 5 of 114 · See all
  • K124027Monster Screw SystemApogee Orthosolutions · 2013 · cites it directly41descendants
  • K101030Modification to HBS Headless Bone ScrewBiopro, Inc. · 2010 · cites it directly40descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991197Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX…Vilex, Inc.1999—
+1K124027Monster Screw SystemApogee Orthosolutions2013—
+1K101030Modification to HBS Headless Bone ScrewBiopro, Inc.20102
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.20121
+1K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.2007—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200730
200820
200920
201010
201110
201210
201370
201420
201550
201610
201780
201850
201950
2020110
202160
2022110
2023140
202480
2025100
2026100
FIG. 1 — Lineage of K991197, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (114)

See all 114

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

NumberDeviceApplicantDecidedDescendants
K124027Monster Screw SystemApogee Orthosolutions201341
K101030Modification to HBS Headless Bone ScrewBiopro, Inc.201040
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.201239
K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.200738
K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159
K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc.20065
K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC20184
K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174
K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC20233
K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited20173

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 Indieations for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6AI4V, implant-quality titanium. 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 510(k) statement, 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/K991197 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991197

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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