510(k) Report

510(k) · Cleared

Cleared

Modification to the I.C.O.S Screw

K011821510(k) TraditionalCleared Sep 6, 200187-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 Sep 6, 2001 as substantially equivalent to K993762 (New Deal, S.A., 2000) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1996. 56 later devices descend from it.

Decided
Sep 6, 2001
Review
87 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K962823 (1996). 4 ancestors in all. 56 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor2005: 1 descendant cleared2009: 1 descendant cleared2007: 1 descendant cleared2016: 3 descendants cleared2013: 2 descendants cleared2014: 2 descendants cleared2021: 5 descendants cleared2017: 6 descendants cleared2023: 4 descendants cleared2026: 9 descendants cleared2015: 3 descendants cleared2022: 4 descendants cleared2018: 2 descendants cleared2020: 3 descendants cleared2019: 3 descendants cleared2025: 3 descendants cleared2024: 4 descendants clearedK962823 · Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer · Synthes (Usa) · 1996K993762 · I.CO.S Screw · New Deal, S.A. · 20001995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 10 descendants4 generations forward: 13 descendants5 generations forward: 14 descendants6 generations forward: 5 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants K993762 · I.CO.S Screw · New Deal, S.A. · 2000K962823 · Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer · Synthes (Usa) · 19960+5
  1. Root · 2 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
  2. 1 generation backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
  3. This deviceK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
  4. Descendant · cites it directly · 55 of its ownK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
  5. Descendant · 2 generations on · 52 of its ownK071639 Qwix Positioning ScrewNewdeal Sas · 2007 · Recalled
  6. Descendant · 2 generations on · 26 of its ownK091798 Merete Compression ScrewsMerete Medical GmbH · 2009
  7. Descendant · 3 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
  8. Descendant · 2 generations on · 18 of its ownK131920 Stabilization ScrewIn2bones Sas · 2014 · Recalled

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12009: 12013: 22014: 22015: 32016: 32017: 62018: 22019: 32020: 32021: 52022: 42023: 42024: 42025: 32026: 9
2005high 9 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 56 · See all
  • K050346Stabilization ScrewNew Deal, S.A. · 2005 · cites it directly55descendants
  • K071639Qwix Positioning ScrewNewdeal Sas · 2007 · 2 generations on52descendants
  • K091798Merete Compression ScrewsMerete Medical GmbH · 2009 · 2 generations on26descendants
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 3 generations on24descendants
  • K131920Stabilization ScrewIn2bones Sas · 2014 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa)1996—
−1K993762I.CO.S ScrewNew Deal, S.A.2000—
0 (this device)K011821Modification to the I.C.O.S ScrewNew Deal, S.A.2001—
+1K050346Stabilization ScrewNew Deal, S.A.20054
+2K071639Qwix Positioning ScrewNewdeal Sas20071
+2K091798Merete Compression ScrewsMerete Medical GmbH2009—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132
+2K131920Stabilization ScrewIn2bones Sas20143

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201320
201420
201530
201630
201760
201820
201930
202030
202150
202240
202340
202440
202530
202690
FIG. 1 — Lineage of K011821, 1996–2026Source: 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? (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
*K993762I.CO.S Screw
Summary page 1
…he surgeon. It also has a self-tapping screw tip. It comes in diameters from 4.0 mm to 6.5 mm and in length from 26 to 90. It is identical in 4esign to the .CO.S® Screw (K993762) INDICATIONS FOR USE: The “new” I.CO.S® Screw is indicated for fixation of bone fractures or for bone reconstruc…
New Deal, S.A.2000—
*K963420Cancellous Screw Washer
Summary page 2
…ly equivalent in design, composition and function to the 1.CO.S™ Screw and to other orthopedics screws manufactured and cleared for market: OrthoFeadic Biosystem Ltd.: K963420 AAP Implants Inc.: K990776 Synthes: K962823 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The “new” 1.CO.S screw is technically…
Orthopaedic Biosystems, Ltd.1996—
*K990776Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
Summary page 2
…mposition and function to the 1.CO.S™ Screw and to other orthopedics screws manufactured and cleared for market: OrthoFeadic Biosystem Ltd.: K963420 AAP Implants Inc.: K990776 Synthes: K962823 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The “new” 1.CO.S screw is technically equivalent to the device cu…
Aap Implantate AG1999—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 2
…ction to the 1.CO.S™ Screw and to other orthopedics screws manufactured and cleared for market: OrthoFeadic Biosystem Ltd.: K963420 AAP Implants Inc.: K990776 Synthes: K962823 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: The “new” 1.CO.S screw is technically equivalent to the device currently approve T…
Synthes (Usa)1996—

Also cleared against K993762: 2 other devices →

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K050346Stabilization ScrewNew Deal, S.A.200555

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 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K050346 (New Deal, S.A., 2005) has gone furthest, with 55 descendants of its own.
  • 2 other devices also cite its predicate K993762.

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” 1.CO.S Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

Fixation of bone fragments, in long bones or small bones fractures.

Fractures management in the foot or hand

Arthrodesis in hand, foot or ankle surgery

Mono or Bi-corticgl osteotomies in the foot or hand or in long bones

Treatment of inferior tibio fibular diastasis

The size of the chosen screw should be adapted to the specific indication.

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 K993762

2 other devices cite the same predicate.

  • K081934Extremity Medical Compression ScrewExtremity Medical, LLC · 2008
  • K024233Kompressor Screw SystemKinetikos Medical, Inc. · 2003

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

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  • 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/K011821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011821: Modification to the I.C.O.S Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011821

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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