510(k) Report

510(k) · Cleared

Recalled · 2009

Cortical Bone Screw

K942340510(k) TraditionalCleared Dec 5, 1994203-day reviewClass II21 CFR 888.3040Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acu Med, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 5, 1994 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it. It has been recalled 3 times.

Decided
Dec 5, 1994
Review
203 days
Class
Class II
Product code
HWC
Recalls
3
Predicates
0

34 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant cleared2026: 6 descendants cleared2014: 2 descendants cleared2022: 2 descendants cleared2016: 4 descendants cleared2015: 2 descendants cleared2019: 3 descendants cleared2018: 1 descendant cleared2024: 4 descendants cleared2023: 3 descendants cleared2021: 1 descendant cleared2025: 3 descendants cleared1990200020102020
  1. This deviceK942340 Cortical Bone ScrewAcu Med, Inc. · 1994
  2. Descendant · cites it directly · 33 of its ownK061206 Acute Bone ScrewAcute Innovations, LLC · 2006
  3. Descendant · 2 generations on · 32 of its ownK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
  4. Descendant · 3 generations on · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
  5. Descendant · 4 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
  6. Descendant · 5 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12012: 12014: 22015: 22016: 42018: 12019: 32021: 12022: 22023: 32024: 42025: 32026: 6
2006high 6 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 34 · See all
  • K061206Acute Bone ScrewAcute Innovations, LLC · 2006 · cites it directly33descendants
  • K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008 · 2 generations on32descendants
  • K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014 · 3 generations on26descendants
  • K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · 4 generations on23descendants
  • K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · 5 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942340Cortical Bone ScrewAcu Med, Inc.1994—
+1K061206Acute Bone ScrewAcute Innovations, LLC2006—
+2K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH2008—
+3K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC2014—
+4K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation2015—
+5K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201210
201420
201520
201640
201810
201930
202110
202220
202330
202440
202530
202660
FIG. 1 — Lineage of K942340, 1994–2026Source: 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.

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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (34)

See all 34

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061206Acute Bone ScrewAcute Innovations, LLC200633

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 19, 2009Not classifiedZ-1602-2010Employee errorMix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
Jul 9, 2007Not classifiedZ-2135-2008Packaging process controlProduct mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
Dec 27, 2005Not classifiedZ-2155-2008Process change controlPackage of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061206 (Acute Innovations, LLC, 2006) has gone furthest, with 33 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 Acu Med, Inc.

43 FDA decisions under this applicant name. See the company

  • K021321Wrist Fusion PlateAcu Med, Inc. · 2002
  • K013616Polarus Cap ScrewAcu Med, Inc. · 2001
  • K012655Congruent Bone Plate SystemAcu Med, Inc. · 200116 recalls
  • K992525Acumed Modular Shoulder SystemAcu Med, Inc. · 20001 recall
  • K993657Acumed Suture AnchorAcu Med, Inc. · 2000

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/K942340 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942340: Cortical 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/K942340

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