510(k) · Cleared
ClearedI.CO.S Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HWC Screw, Fixation, Bone
Cleared on Feb 4, 2000 as substantially equivalent to K963420 (Orthopaedic Biosystems, Ltd., 1996) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1996. 1 of the 342 devices in its family, counting itself, has a Class I recall. 338 later devices descend from it.
- Decided
- Feb 4, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K962823 (1996). 3 ancestors in all. 338 later devices descend from it, 3 citing it directly. 1 of the 342 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- This deviceK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- Descendant · cites it directly · 299 of its ownK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- Descendant · 2 generations on · 255 of its ownK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- Descendant · 3 generations on · 251 of its ownK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- Descendant · 4 generations on · 246 of its ownK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- Descendant · 5 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
Showing 5 of 338 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 338 · See all- K024233Kompressor Screw SystemKinetikos Medical, Inc. · 2003 · cites it directly299descendants
- K040356Kompressor Screw SystemKinetikos Medical, Inc. · 2004 · 2 generations on255descendants
- K060071Nexa Compression ScrewNexa Orthopedics, Inc. · 2006 · 3 generations on251descendants
- K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007 · 4 generations on246descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 5 generations on161descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| 0 (this device) | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| +1 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| +2 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| +3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| +4 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| +5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 19 | 0 |
| 2016 | 11 | 0 |
| 2017 | 23 | 0 |
| 2018 | 10 | 0 |
| 2019 | 17 | 0 |
| 2020 | 20 | 0 |
| 2021 | 26 | 1 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 31 | 0 |
| 2025 | 32 | 0 |
| 2026 | 45 | 0 |
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.
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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963420 | Cancellous Screw WasherSummary page 2….S® Screw is substantially equivalent in design, composition and function to other orthopedics screws manufactured and approved for market: Orthopeadic Biosystem Ltd.: K963420 AAP Implants Inc.: K990776 Synthes: K962823 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the L.CO.S® Screw , the Self-dr… | 1996 |
| * | K990776 | Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MMSummary page 2…quivalent in design, composition and function to other orthopedics screws manufactured and approved for market: Orthopeadic Biosystem Ltd.: K963420 AAP Implants Inc.: K990776 Synthes: K962823 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the L.CO.S® Screw , the Self-drilling Facet Screw from Orth… | 1999 |
| * | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSummary page 2…n, composition and function to other orthopedics screws manufactured and approved for market: Orthopeadic Biosystem Ltd.: K963420 AAP Implants Inc.: K990776 Synthes: K962823 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the L.CO.S® Screw , the Self-drilling Facet Screw from Orthopaedic Biosystems… | 1996 |
What descends from it? (338)
See all 3383 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The ICOS ® SCREW is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation in the forefoot and/or mid foot and /or hindfoot, including;
*naviculo-cunéiform arthrodesis
*lapidus arthrodesis
*talus osteochondritis
*ankle arthrodesis
*arthrodesis, osteotomies or fractures fixation in the forefoot and/or midfoot and/or the hindfoot.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993762: I.CO.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/K993762
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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