510(k) Report

510(k) · Cleared

Cleared

Healix™ Compression Screw System

K182949510(k) TraditionalCleared Dec 4, 201842-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

Nvision Biomedical Technologies, LLC · HWC Screw, Fixation, Bone

Cleared on Dec 4, 2018 as substantially equivalent to K014154 (Vilex, Inc., 2002) and 4 other predicates after a 42-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.

Decided
Dec 4, 2018
Review
42 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K973309 (1998). 5 ancestors in all. 4 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2002: 1 other ancestor1999: 2 other ancestors2020: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK973309 · Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw · Vilex, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants K973309 · Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw · Vilex, Inc. · 19980
  1. Root · 1 generation backK973309 Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc. · 1998
  2. This deviceK182949 Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  3. Descendant · cites it directly · 1 of its ownK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
  4. Descendant · cites it directly · 0 of its ownK260291 Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
  5. Descendant · cites it directly · 0 of its ownK242896 Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025
  6. Descendant · cites it directly · 0 of its ownK200914 Healix Compression Screw SystemNvision Biomedical Technologies, Inc. · 2020

Most influential descendants

Showing 4 of 4 · See all
  • K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly1descendant
  • K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026 · cites it directly0descendants
  • K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025 · cites it directly0descendants
  • K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973309Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc.1998—
0 (this device)K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC2018—
+1K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.2020—
+1K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.2026—
+1K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies2025—
+1K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
200210
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202510
202610
FIG. 1 — Lineage of K182949, 1998–2026Source: 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K014154Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…
Summary page 5
…10(k) Number Predicate Device Name / Manufacturer Primary Predicate K014154 Vilex Cannulated Bone Screw System* 9 K081149 BioPro GO-EZ Screw System *Prior Vilex Ca…
Vilex, Inc.2002—
*K081149Biopro GO-EZ Screw
Summary page 5
…Predicate K014154 Vilex Cannulated Bone Screw System* 9 K081149 BioPro GO-EZ Screw System *Prior Vilex Cannulated Bone Screw System submissions also include K991151, K991197, and K973309 SU…
Biopro, Inc.200814
*K991151Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw
Summary page 5
…nnulated Bone Screw System* 9 K081149 BioPro GO-EZ Screw System *Prior Vilex Cannulated Bone Screw System submissions also include K991151, K991197, and K973309 SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the HEALIX Compress…
Vilex, Inc.1999—
*K991197Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…
Summary page 5
…Bone Screw System* 9 K081149 BioPro GO-EZ Screw System *Prior Vilex Cannulated Bone Screw System submissions also include K991151, K991197, and K973309 SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the HEALIX Compression Screw…
Vilex, Inc.1999—
*K973309Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw
Summary page 5
…stem* 9 K081149 BioPro GO-EZ Screw System *Prior Vilex Cannulated Bone Screw System submissions also include K991151, K991197, and K973309 SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the HEALIX Compression Screw System. The…
Vilex, Inc.1998—

Also cleared against K014154: 15 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260
K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies20250
K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.20200

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K202657 (Nvision Biomedical Technologies, Inc., 2020) has gone furthest, with 1 descendant of its own.
  • 15 other devices also cite its predicate K014154.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

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 HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

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

Also cleared against K014154

15 other devices cite the same predicate.

  • K250304TITANEX Screw SystemsVilex, LLC · 2025
  • K221342REDEMPTION Beaming SystemVilex, LLC · 2022
  • K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc. · 2020
  • K173286Cannulated Screw Internal Fixation SystemLife Spine, Inc. · 2017
  • K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 20171 recall
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017

More from Nvision Biomedical Technologies, LLC

10 FDA decisions under this applicant name. See the company

  • K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC · 2019
  • K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
  • K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC · 2017
  • K170074nvcNvision Biomedical Technologies, LLC · 2017

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/K182949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182949: Healix™ Compression Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182949

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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