510(k) Report

510(k) · Cleared

Cleared

The Spin Snap-Off Screw

K011946510(k) TraditionalCleared Aug 24, 200164-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

New Deal, S.A. · HWC Screw, Fixation, Bone

Cleared on Aug 24, 2001 as substantially equivalent to K991477 (New Deal, S.A., 1999) and 6 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1993. 6 later devices descend from it.

Decided
Aug 24, 2001
Review
64 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K924138 (1993). 7 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1995: 2 other ancestors1993: 1 other ancestor2017: 2 descendants cleared2005: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared2016: 1 descendant clearedK924138 · Osteomed M3 System (SBF System) · Osteomed Corp. · 1993K962233 · Twist-Off Screw · Landos, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants K962233 · Twist-Off Screw · Landos, Inc. · 1996K924138 · Osteomed M3 System (SBF System) · Osteomed Corp. · 19930
  1. Root · 2 generations backK924138 Osteomed M3 System (SBF System)Osteomed Corp. · 1993
  2. 1 generation backK962233 Twist-Off ScrewLandos, Inc. · 1996
  3. This deviceK011946 The Spin Snap-Off ScrewNew Deal, S.A. · 2001
  4. Descendant · cites it directly · 2 of its ownK051323 Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH · 2005
  5. Descendant · cites it directly · 0 of its ownK253108 VEOFIX Snap Off ScrewSteps Ortho · 2026
  6. Descendant · cites it directly · 0 of its ownK210016 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra…Integra LifeSciences Corporation · 2021
  7. Descendant · cites it directly · 0 of its ownK163710 BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017
  8. Descendant · 2 generations on · 0 of its ownK170012 Foot and Hand MotionNewclip Technics · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12016: 12017: 22021: 12026: 1
2005high 2 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH · 2005 · cites it directly2descendants
  • K253108VEOFIX Snap Off ScrewSteps Ortho · 2026 · cites it directly0descendants
  • K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation · 2021 · cites it directly0descendants
  • K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017 · cites it directly0descendants
  • K170012Foot and Hand MotionNewclip Technics · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K924138Osteomed M3 System (SBF System)Osteomed Corp.1993—
−1K962233Twist-Off ScrewLandos, Inc.1996—
0 (this device)K011946The Spin Snap-Off ScrewNew Deal, S.A.2001—
+1K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH2005—
+1K253108VEOFIX Snap Off ScrewSteps Ortho2026—
+1K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation2021—
+1K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie2017—
+2K170012Foot and Hand MotionNewclip Technics2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199520
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201610
201720
202110
202610
FIG. 1 — Lineage of K011946, 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? (7)

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
*K991477Spin Snap-Off Screw
Summary page 2
…s and fractures fixation in the foot and hand PREDICATE DEVICE: The “new” SPIN® SNAP-OFF SCREW is technically equivalent to the SPIN* SNAP-OFF screw currently approved (K991477). The “ncw” SPIN™ SNAP-OFF SCREW is substantially equivalent to the Depuy Twist-off Screw (K962233). the howmedica Luhr Screw sys…
New Deal, S.A.1999—
*K962233Twist-Off Screw
Summary page 2
…technically equivalent to the SPIN* SNAP-OFF screw currently approved (K991477). The “ncw” SPIN™ SNAP-OFF SCREW is substantially equivalent to the Depuy Twist-off Screw (K962233). the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Sc…
Landos, Inc.1996—
*K950595Luhr Mandibular/Small Fixation Implants
Summary page 2
…F screw currently approved (K991477). The “ncw” SPIN™ SNAP-OFF SCREW is substantially equivalent to the Depuy Twist-off Screw (K962233). the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Screw (K924018, K924138). COMPARISON OF TECH…
Howmedica Corp.1995—
*K952272TI. Alloy 2.0 MM Cortex Screw
Summary page 2
…™ SNAP-OFF SCREW is substantially equivalent to the Depuy Twist-off Screw (K962233). the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Screw (K924018, K924138). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The “new” SPIN® SNAP-OFF…
Synthes (Usa)1995—
*K0022712.4MM Cortex Screw, Self-Tapping
Summary page 2
…SCREW is substantially equivalent to the Depuy Twist-off Screw (K962233). the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Screw (K924018, K924138). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The “new” SPIN® SNAP-OFF screw is t…
Synthes (Usa)2000—
*K924018M3 Lag Screw Fixation System
Summary page 2
…the Depuy Twist-off Screw (K962233). the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Screw (K924018, K924138). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The “new” SPIN® SNAP-OFF screw is technically equivalent to the device…
Osteomed Corp.1993—
*K924138Osteomed M3 System (SBF System)
Summary page 2
…y Twist-off Screw (K962233). the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Screw (K924018, K924138). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The “new” SPIN® SNAP-OFF screw is technically equivalent to the device currently…
Osteomed Corp.1993—

Also cleared against K991477: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH20052
K253108VEOFIX Snap Off ScrewSteps Ortho20260
K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210
K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie20170

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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K051323 (Merete Medical GmbH, 2005) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K991477.

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 “new” SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

Fixation of small bone fragments.

Weil osteotomy

Mono-cortical fixation

Osteotomies and fractures fixation in the foot and hand

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 K991477

4 other devices cite the same predicate.

  • K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc. · 2019
  • K150772Snap-Off Self-Compressive ScrewNeosteo · 2015
  • K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas · 2014
  • K112794Eos Small Bone Fixation SystemTriMed, Inc. · 20124 recalls

More from New Deal, S.A.

28 FDA decisions under this applicant name. See the company

  • K070160Modification to TTC PlatesNew Deal, S.A. · 2007
  • K063820Lisfranc PlateNew Deal, S.A. · 2007
  • K070241Modification to Lapidus PlateNew Deal, S.A. · 20071 recall
  • K060474Lisfranc PlateNew Deal, S.A. · 2006
  • K061765Kalix II ImplantNew Deal, S.A. · 2006

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/K011946 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011946: The Spin Snap-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/K011946

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 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026