510(k) · Cleared
ClearedNexis osteosynthesis compressive 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) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1979. 3 later devices descend from it.
- Decided
- Feb 6, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K792022 (1979). 10 ancestors in all. 3 later devices descend from it, 3 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 deviceK143229 Nexis osteosynthesis compressive screwsNovastep · 2015
- Descendant · cites it directly · 0 of its ownK223468 Nexis® compressive screwsNovastep · 2023
- Descendant · cites it directly · 0 of its ownK230397 Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda. · 2023
- Descendant · cites it directly · 0 of its ownK221090 Metal Cannulated ScrewDouble Medical Technology, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K223468Nexis® compressive screwsNovastep · 2023 · cites it directly0descendants
- K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda. · 2023 · cites it directly0descendants
- K221090Metal Cannulated ScrewDouble Medical Technology, Inc. · 2023 · cites it directly0descendants
View 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) | K143229 | Nexis osteosynthesis compressive screws | Novastep | 2015 | — |
| +1 | K223468 | Nexis® compressive screws | Novastep | 2023 | — |
| +1 | K230397 | Cut Screw - Percutaneous Compression Screw | GM Dos Reis Industria e Comercio Ltda. | 2023 | — |
| +1 | K221090 | Metal Cannulated Screw | Double Medical Technology, Inc. | 2023 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K070039 | Memometal Fixos ScrewsSummary page 5…ds for Metallic Medical Bone Screws) and thus are believed to be substantially equivalent to the predicate Memometal Fixos screws (device references: S-Fix/C-Fix/P-Fix) (K070039) and SBI Autofix™ System (K052576). Performance data [ | | | | | The biocompatibility evaluation for new devices Nexis® osteos… | 2007 |
| * | K052576 | Sbi AutofixSummary page 4…eidevicss Device name: Memometal Fixos screws Original applicant: MEMOMETAL TECHNOLOGIES This predicate has not been subject to a design-related recall. 510(k) number: K052576 Device name: SBI Autofix™ System novastep - Siege Social / Service Client Espace Performance - Alphasis - Batiment C1-C2 - 3576… | 2005 |
What descends from it? (3)
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?
- The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K223468 (Novastep, 2023) has gone furthest, with 0 descendants 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 indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and 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/K143229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143229: Nexis osteosynthesis compressive screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143229
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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