510(k) · Cleared
ClearedSpin Snap-Off 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 Jul 14, 1999 after a 77-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.
- Decided
- Jul 14, 1999
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 5 citing it directly.
- This deviceK991477 Spin Snap-Off ScrewNew Deal, S.A. · 1999
- Descendant · cites it directly · 9 of its ownK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 7 of its ownK153395 OS2-C Compression StapleIn2bones Sas · 2016
- Descendant · cites it directly · 6 of its ownK011946 The Spin Snap-Off ScrewNew Deal, S.A. · 2001
- Descendant · 3 generations on · 3 of its ownK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- Descendant · 3 generations on · 2 of its ownK212594 OSSIOfiber® StapleOSSIO, Ltd. · 2022
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K112794Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · cites it directly9descendants
- K153395OS2-C Compression StapleIn2bones Sas · 2016 · 2 generations on7descendants
- K011946The Spin Snap-Off ScrewNew Deal, S.A. · 2001 · cites it directly6descendants
- K163440Stealth Staple SystemFirst Ray, LLC · 2017 · 3 generations on3descendants
- K212594OSSIOfiber® StapleOSSIO, Ltd. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991477 | Spin Snap-Off Screw | New Deal, S.A. | 1999 | — |
| +1 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| +2 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| +1 | K011946 | The Spin Snap-Off Screw | New Deal, S.A. | 2001 | — |
| +3 | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
| +3 | K212594 | OSSIOfiber® Staple | OSSIO, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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.
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Depuy Twist-off Screw Named without a submission number | |
| * | — | Howmedica Luhr Screw system Named without a submission number | |
| * | — | Synthes Cortex Screw Named without a submission number | |
| * | — | Osteomed M3 Screw Named without a submission number |
What descends from it? (22)
See all 225 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K112794 (TriMed, Inc., 2012) has gone furthest, with 9 descendants of its own.
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 SPIN® SNAP-OFF SCREW is indicated for fixing the elective osteotomies in the metatarsal and phalanges of the foot only. Examples include:
Weil osteotomy
Lesser metatarsal osteotomies
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/K991477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991477: 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/K991477
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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