510(k) · Cleared
ClearedSelf-Compressive Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neosteo · HWC Screw, Fixation, Bone
Cleared on Aug 28, 2013 as substantially equivalent to K091118 (Newclip Technics, 2009) after a 98-day review. Its family tree reaches back 1 generation to 2009. 4 later devices descend from it.
- Decided
- Aug 28, 2013
- Review
- 98 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091118 (2009). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK091118 Foot and Hand Motion SystemNewclip Technics · 2009
- This deviceK131471 Self-Compressive ScrewNeosteo · 2013
- Descendant · cites it directly · 1 of its ownK153182 Self- Compressive ScrewNeosteo · 2015
- Descendant · cites it directly · 1 of its ownK150772 Snap-Off Self-Compressive ScrewNeosteo · 2015
- Descendant · 2 generations on · 0 of its ownK250536 MetaFore Small Screw SystemExtremity Medical, LLC · 2025
- Descendant · cites it directly · 0 of its ownK232605 Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES…Lesspine Innovations · 2023
Most influential descendants
Showing 4 of 4 · See all- K153182Self- Compressive ScrewNeosteo · 2015 · cites it directly1descendant
- K150772Snap-Off Self-Compressive ScrewNeosteo · 2015 · cites it directly1descendant
- K250536MetaFore Small Screw SystemExtremity Medical, LLC · 2025 · 2 generations on0descendants
- K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091118 | Foot and Hand Motion System | Newclip Technics | 2009 | — |
| 0 (this device) | K131471 | Self-Compressive Screw | Neosteo | 2013 | — |
| +1 | K153182 | Self- Compressive Screw | Neosteo | 2015 | — |
| +1 | K150772 | Snap-Off Self-Compressive Screw | Neosteo | 2015 | — |
| +2 | K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025 | — |
| +1 | K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System… | Lesspine Innovations | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K091118 | Foot and Hand Motion SystemSummary page 2…Self-Compressive Screw is similar to the following predicate device which has been cleared via the premarket notification process: Newciip Foot and Hand Motion System (1(091118). Page 2 / 4… | 2009 |
What descends from it? (4)
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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Self-Compressive Screws are Intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131471 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131471: Self-Compressive Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131471
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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