510(k) · Cleared
ClearedLeforte Neurosystem Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · HWC Screw, Fixation, Bone
Cleared on Nov 13, 2009 as substantially equivalent to K042365 (Synthes (Usa), 2004) and 1 other predicate after a 157-day review. Its family tree reaches back 3 generations to 1996. 29 later devices descend from it.
- Decided
- Nov 13, 2009
- Review
- 157 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953806 (1996). 4 ancestors in all. 29 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 2 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 1 generation backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- This deviceK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- Descendant · cites it directly · 16 of its ownK112457 Leforte System Bone Plate & ScrewArkin Consulting Group · 2012
- Descendant · cites it directly · 11 of its ownK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- Descendant · 2 generations on · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
- Descendant · 3 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
- Descendant · 4 generations on · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K112457Leforte System Bone Plate & ScrewArkin Consulting Group · 2012 · cites it directly16descendants
- K112812Leforte Neuro System Bone PlateJeil Medical Corporation · 2012 · cites it directly11descendants
- K131311Arix Foot SystemJeil Medical Corporation · 2013 · 2 generations on9descendants
- K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 3 generations on5descendants
- K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −2 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −1 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| 0 (this device) | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| +1 | K112457 | Leforte System Bone Plate & Screw | Arkin Consulting Group | 2012 | — |
| +1 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| +2 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| +3 | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
| +4 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K042365 | Synthes (Usa) Neuro Plate and Screw SystemSummary page 1…Marketed Device Pl1 rt, Binc (Mode!: Synthes (USA) Neuro Plate and Screw System) manufactured by Syntht, (USA) - _K042365, Decision Date: 11/18/2004, JEY (Class 11per regulation 21CRF 872.4760)… | 2004 |
| * | K021850 | Synthes (Usa) 1.3 MM Craniofacial ScrewsSummary page 2…ge 2 === 2) Screw, Fixation, Intraosseous (Model: Synthes (USA) 1.3mm Craniofacial Screws) manufactured by Synth~s (USA) - K021850 Decision Date: 06/10/2002, DZL (Class II per regulation 2ICFR 872.4880) 6. I 3sci-ition of the Device… | 2002 |
What descends from it? (29)
See all 292 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 13 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K112457 (Arkin Consulting Group, 2012) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K042365.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091686: Leforte Neurosystem Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091686
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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