510(k) · Cleared
ClearedSnap-Off Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · HWC Screw, Fixation, Bone
Cleared on Aug 25, 2004 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 25, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK041456 Snap-Off ScrewsFournitures Hospitalieres Industrie · 2004
- Descendant · cites it directly · 4 of its ownK070617 Cannulated ScrewFournitures Hospitalieres Industrie · 2007
- Descendant · cites it directly · 0 of its ownK163710 BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017
- Descendant · 2 generations on · 0 of its ownK170040 BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017
- Descendant · cites it directly · 0 of its ownK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
- Descendant · 2 generations on · 0 of its ownK150471 CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070617Cannulated ScrewFournitures Hospitalieres Industrie · 2007 · cites it directly4descendants
- K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017 · cites it directly0descendants
- K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017 · 2 generations on0descendants
- K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015 · cites it directly0descendants
- K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041456 | Snap-Off Screws | Fournitures Hospitalieres Industrie | 2004 | — |
| +1 | K070617 | Cannulated Screw | Fournitures Hospitalieres Industrie | 2007 | — |
| +1 | K163710 | BePOD® EZ Weil Screws | Fournitures Hospitalieres Industrie | 2017 | — |
| +2 | K170040 | BePOD Cannulated Arthrodesis Screws | Fournitures Hospitalieres Industrie | 2017 | — |
| +1 | K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015 | — |
| +2 | K150471 | CalcaNail Orthopedic Arthrodesis Nail | Fournitures Hospitalieres Industrie | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
3 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, K070617 (Fournitures Hospitalieres Industrie, 2007) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K041456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041456: Snap-Off Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041456
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026