510(k) · Cleared
ClearedNexis osteosynthesis snap-off screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novastep · HWC Screw, Fixation, Bone
Cleared on Feb 6, 2015 as substantially equivalent to K070039 (Memometal Technologies, 2007) after a 95-day review. Its family tree reaches back 3 generations to 1979. 2 later devices descend from it.
- Decided
- Feb 6, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K792022 (1979). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 2 generations backK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- 1 generation backK070039 Memometal Fixos ScrewsMemometal Technologies · 2007
- This deviceK143146 Nexis osteosynthesis snap-off screwsNovastep · 2015
- Descendant · cites it directly · 1 of its ownK220921 Metal Bone ScrewDouble Medical Technology, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242348 Locking Screw,CoCrMoDouble Medical Technology, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −2 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| −1 | K070039 | Memometal Fixos Screws | Memometal Technologies | 2007 | — |
| 0 (this device) | K143146 | Nexis osteosynthesis snap-off screws | Novastep | 2015 | — |
| +1 | K220921 | Metal Bone Screw | Double Medical Technology, Inc. | 2022 | — |
| +2 | K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K070039 | Memometal Fixos ScrewsSummary page 4…= T — Classification Name Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, product code HWC) ‘ | Regulatory class Il Legally marketed | 510(k) number: K070039 | predicate devi L preicate devies Device name: Memometal Fixos screws ‘- Original applicant: MEMOMETAL TECHNOLOGIES | This predi… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220921 | Metal Bone Screw | 2022 | 1 |
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 36 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K220921 (Double Medical Technology, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K070039.
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 Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
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/K143146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143146: Nexis osteosynthesis snap-off screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143146
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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