510(k) Report

510(k) · Cleared

Cleared

M3 Lag Screw Fixation System

K924018510(k) TraditionalCleared Apr 1, 1993233-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

Osteomed Corp. · HWC Screw, Fixation, Bone

Cleared on Apr 1, 1993 after a 233-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 581 devices in its family, counting itself, has a Class I recall. 580 later devices descend from it.

Decided
Apr 1, 1993
Review
233 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

580 later devices descend from it, 12 citing it directly. 1 of the 581 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1996: 4 descendants cleared1999: 1 descendant cleared1998: 1 descendant cleared2015: 35 descendants cleared2014: 23 descendants cleared1997: 1 descendant cleared2012: 15 descendants cleared2013: 12 descendants cleared2001: 1 descendant cleared2017: 45 descendants cleared2005: 2 descendants cleared2021: 45 descendants cleared, 1 with a Class I recall12026: 71 descendants cleared2019: 32 descendants cleared2022: 38 descendants cleared2020: 37 descendants cleared2023: 45 descendants cleared2018: 23 descendants cleared2003: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared2016: 18 descendants cleared2009: 2 descendants cleared2025: 55 descendants cleared2011: 9 descendants cleared2010: 3 descendants cleared2024: 58 descendants cleared1990200020102020
  1. This deviceK924018 M3 Lag Screw Fixation SystemOsteomed Corp. · 1993
  2. Descendant · cites it directly · 548 of its ownK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
  3. Descendant · 2 generations on · 527 of its ownK062352 FRS ScrewDePuy Orthopaedics, Inc. · 2006
  4. Descendant · 3 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  6. Descendant · 4 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011

Showing 5 of 580 descendants. See all descendants

Descendants cleared per year

1996: 41997: 11998: 11999: 12001: 12003: 12005: 22006: 12007: 22009: 22010: 32011: 92012: 152013: 122014: 232015: 352016: 182017: 452018: 232019: 322020: 372021: 452022: 382023: 452024: 582025: 552026: 71
1996high 71 (2026) · low 0 (2000)2026

Class I recalls in this family

  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 580 · See all
  • K962236Scarf Thread-Head ScrewLandos, Inc. · 1996 · cites it directly548descendants
  • K062352FRS ScrewDePuy Orthopaedics, Inc. · 2006 · 2 generations on527descendants
  • K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 3 generations on487descendants
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants
  • K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 4 generations on161descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924018M3 Lag Screw Fixation SystemOsteomed Corp.1993—
+1K962236Scarf Thread-Head ScrewLandos, Inc.1996—
+2K062352FRS ScrewDePuy Orthopaedics, Inc.2006—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199640
199710
199810
199910
200110
200310
200520
200610
200720
200920
201030
201190
2012150
2013120
2014230
2015350
2016180
2017450
2018230
2019320
2020370
2021451
2022380
2023450
2024580
2025550
2026710
FIG. 1 — Lineage of K924018, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (580)

See all 580

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

NumberDeviceApplicantDecidedDescendants
K962236Scarf Thread-Head ScrewLandos, Inc.1996548
K962233Twist-Off ScrewLandos, Inc.199692
K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579
K960533K3 Bone Screw SystemKinetikos Medical, Inc.199661
K124027Monster Screw SystemApogee Orthosolutions201341
K960537K2 Bone Screw SystemKinetikos Medical, Inc.199641
K140397Paralock Plating System / Tuffnek ScrewParagon 28201431
K011946The Spin Snap-Off ScrewNew Deal, S.A.20016
K120015Osteomed Wrist Plating SystemOsteomed LP20122
K990019DRG Medium Screw SystemDolphin Medical Technologies, Inc.19990

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K962236 (Landos, Inc., 1996) has gone furthest, with 548 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—

More from Osteomed Corp.

27 FDA decisions under this applicant name. See the company

  • K151021OsteoMed Cannulated Screw SystemOsteomed Corp. · 2015
  • K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
  • K022887Interphalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K022886Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002

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/K924018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924018: M3 Lag Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924018

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026