510(k) Report

510(k) · Cleared

Cleared

Twist-Off Screw

K962233510(k) TraditionalCleared Oct 3, 1996114-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

Landos, Inc. · HWC Screw, Fixation, Bone

Cleared on Oct 3, 1996 as substantially equivalent to K924018 (Osteomed Corp., 1993) and 3 other predicates after a 114-day review. Its family tree reaches back 1 generation to 1993. 92 later devices descend from it.

Decided
Oct 3, 1996
Review
114 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K924138 (1993). 4 ancestors in all. 92 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors1993: 1 other ancestor2014: 2 descendants cleared2007: 1 descendant cleared2001: 1 descendant cleared2017: 6 descendants cleared2005: 1 descendant cleared2021: 5 descendants cleared2026: 11 descendants cleared2015: 6 descendants cleared2013: 2 descendants cleared2012: 1 descendant cleared2022: 13 descendants cleared2018: 1 descendant cleared2019: 6 descendants cleared2016: 1 descendant cleared2025: 5 descendants cleared2023: 13 descendants cleared2020: 6 descendants cleared2024: 11 descendants clearedK924138 · Osteomed M3 System (SBF System) · Osteomed Corp. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 27 descendants4 generations forward: 27 descendants5 generations forward: 16 descendants6 generations forward: 5 descendants7 generations forward: 2 descendants K924138 · Osteomed M3 System (SBF System) · Osteomed Corp. · 19930+5
  1. Root · 1 generation backK924138 Osteomed M3 System (SBF System)Osteomed Corp. · 1993
  2. This deviceK962233 Twist-Off ScrewLandos, Inc. · 1996
  3. Descendant · cites it directly · 84 of its ownK070039 Memometal Fixos ScrewsMemometal Technologies · 2007
  4. Descendant · 2 generations on · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
  5. Descendant · cites it directly · 36 of its ownK142658 Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · Recalled
  6. Descendant · 3 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
  7. Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2001: 12005: 12007: 12012: 12013: 22014: 22015: 62016: 12017: 62018: 12019: 62020: 62021: 52022: 132023: 132024: 112025: 52026: 11
2001high 13 (2022) · low 0 (2002)2026

Most influential descendants

Showing 5 of 92 · See all
  • K070039Memometal Fixos ScrewsMemometal Technologies · 2007 · cites it directly84descendants
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · 2 generations on39descendants
  • K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · cites it directly36descendants
  • K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 3 generations on36descendants
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924138Osteomed M3 System (SBF System)Osteomed Corp.1993—
0 (this device)K962233Twist-Off ScrewLandos, Inc.1996—
+1K070039Memometal Fixos ScrewsMemometal Technologies2007—
+2K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.20121
+1K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp20142
+3K123890Acumed Cannulated Screw SystemAcumed, LLC20132
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200510
200710
201210
201320
201420
201560
201610
201760
201810
201960
202060
202150
2022130
2023130
2024110
202550
2026110
FIG. 1 — Lineage of K962233, 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), 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? (4)

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
*K924018M3 Lag Screw Fixation System
Summary page 2
…ns. The TWIST-OFF™ SCREW is indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot. The TWIST-OFF™ SCREW is substantially (K924018, K924138), the Luhr Screw System (Howmedica)(K950595) and the Cortex Screw (Synthes)(K952272). Both the TWIST-OFF™ SCREW and its…
Osteomed Corp.1993—
*K924138Osteomed M3 System (SBF System)
Summary page 2
…TWIST-OFF™ SCREW is indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot. The TWIST-OFF™ SCREW is substantially (K924018, K924138), the Luhr Screw System (Howmedica)(K950595) and the Cortex Screw (Synthes)(K952272). Both the TWIST-OFF™ SCREW and its predicat…
Osteomed Corp.1993—
*K950595Luhr Mandibular/Small Fixation Implants
Summary page 2
…stabilizing elective osteotomies of metatarsals and phalanges of the foot. The TWIST-OFF™ SCREW is substantially (K924018, K924138), the Luhr Screw System (Howmedica)(K950595) and the Cortex Screw (Synthes)(K952272). Both the TWIST-OFF™ SCREW and its predicates have the same intended use. All are used…
Howmedica Corp.1995—
*K952272TI. Alloy 2.0 MM Cortex Screw
Summary page 2
…atarsals and phalanges of the foot. The TWIST-OFF™ SCREW is substantially (K924018, K924138), the Luhr Screw System (Howmedica)(K950595) and the Cortex Screw (Synthes)(K952272). Both the TWIST-OFF™ SCREW and its predicates have the same intended use. All are used for fixation of small bones. The M3 and…
Synthes (Usa)1995—

Also cleared against K924018: 11 other devices →

What descends from it? (92)

See all 92

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

NumberDeviceApplicantDecidedDescendants
K070039Memometal Fixos ScrewsMemometal Technologies200784
K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp201436
K011946The Spin Snap-Off ScrewNew Deal, S.A.20016

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K070039 (Memometal Technologies, 2007) has gone furthest, with 84 descendants of its own.
  • 11 other devices also cite its predicate K924018.

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 TWIST-OFF™ SCREW is indicated for fixing and stabilizing elective osteotomies of metatarsals and phalanges of the foot.

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 K924018

11 other devices cite the same predicate.

  • K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  • K124027Monster Screw SystemApogee Orthosolutions · 2013
  • K120015Osteomed Wrist Plating SystemOsteomed LP · 2012
  • K011946The Spin Snap-Off ScrewNew Deal, S.A. · 2001
  • K990019DRG Medium Screw SystemDolphin Medical Technologies, Inc. · 1999

More from Landos, Inc.

15 FDA decisions under this applicant name. See the company

  • K964226Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  • K97106834MM Scarf Thread-Head (TM) ScrewLandos, Inc. · 1997
  • K971069Twist-Off (TM) ScrewLandos, Inc. · 1997
  • K971070Scarf Thread-Head (TM) Head ScrewLandos, Inc. · 1997
  • K961732KARLandos, Inc. · 1997

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/K962233 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962233: Twist-Off Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962233

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026