510(k) · Cleared
ClearedSnap-Off Self-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 May 8, 2015 as substantially equivalent to K991477 (New Deal, S.A., 1999) and 1 other predicate after a 45-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- May 8, 2015
- Review
- 45 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K091118 (2009). 3 ancestors in all, the oldest K991477 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK091118 Foot and Hand Motion SystemNewclip Technics · 2009
- 1 generation backK131471 Self-Compressive ScrewNeosteo · 2013
- This deviceK150772 Snap-Off Self-Compressive ScrewNeosteo · 2015
- Descendant · cites it directly · 0 of its ownK250536 MetaFore Small Screw SystemExtremity Medical, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K250536MetaFore Small Screw SystemExtremity Medical, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091118 | Foot and Hand Motion System | Newclip Technics | 2009 | — |
| −1 | K131471 | Self-Compressive Screw | Neosteo | 2013 | — |
| 0 (this device) | K150772 | Snap-Off Self-Compressive Screw | Neosteo | 2015 | — |
| +1 | K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K991477 | Spin Snap-Off ScrewSummary page 5…87 “Orthopedic” Product code HWC Primary Predicate Device Spin® Snap-Off Screw (K991477) from NewDeal SA Secondary Predicate Device Self-Compressive Screws (K131471) from Neosteo III. DEVIC… | 1999 |
| * | K131471 | Self-Compressive ScrewSummary page 5…HWC Primary Predicate Device Spin® Snap-Off Screw (K991477) from NewDeal SA Secondary Predicate Device Self-Compressive Screws (K131471) from Neosteo III. DEVICE DESCRIPTION The Snap-Off Self-Compressive Screw consists of screws available in several le… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250536 | MetaFore Small Screw System | 2025 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K250536 (Extremity Medical, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K991477.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Snap-Off 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/K150772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150772: Snap-Off Self-Compressive Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150772
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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