510(k) · Cleared
ClearedLeforte Neuro System Bone Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Feb 22, 2012 as substantially equivalent to K091679 (Jeil Medical Corporation, 2009) and 2 other predicates after a 148-day review. Its family tree reaches back 4 generations to 1996. 11 later devices descend from it.
- Decided
- Feb 22, 2012
- Review
- 148 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953806 (1996). 7 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 3 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 2 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 1 generation backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- This deviceK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- Descendant · cites it directly · 4 of its ownK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK141452 Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation · 2014
- Descendant · 2 generations on · 2 of its ownK210099 Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K141911Optimus Neuro SystemOsteonic Co., Ltd. · 2015 · cites it directly4descendants
- K141452Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation · 2014 · cites it directly4descendants
- K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd. · 2021 · 2 generations on2descendants
- K183352Optimus Neuro SystemOsteonic Co., Ltd. · 2019 · 2 generations on2descendants
- K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −3 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −2 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −1 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| 0 (this device) | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| +1 | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| +1 | K141452 | Leforte Neuro System Bone Plate and Screw | Jeil Medical Corporation | 2014 | — |
| +2 | K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | 2021 | — |
| +2 | K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019 | — |
| +2 | K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 2 | 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 GWO? 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 GWO device
- #1 K261058 CraniUS Platescore 16.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K091679 | Leforte System Bone PlateSummary page 1…Fastener, Plate, Cranioplasty 3. Predicate Devices: Jeil Medical Corporation! LeForte Neuro System Bone Plate / K091679 Jeil Medical Corporation! LeForte Neuro System Bone Plate / K103778 Jeil Medical Corporat… | 2009 |
| * | K103778 | Leforte Neuro System Bone PlateSummary page 1…: Jeil Medical Corporation! LeForte Neuro System Bone Plate / K091679 Jeil Medical Corporation! LeForte Neuro System Bone Plate / K103778 Jeil Medical Corporation! LeForte Neuro System Bone Screw / K09 1686 4. Regulatory Classificati… | 2011 |
| * | K091686 | Leforte Neurosystem Bone ScrewSummary page 1…9 Jeil Medical Corporation! LeForte Neuro System Bone Plate / K103778 Jeil Medical Corporation! LeForte Neuro System Bone Screw / K09 1686 4. Regulatory Classifications, Product Code: 2 1CFR882.5320, GWO, Class 11 2 1CFR88… | 2009 |
What descends from it? (11)
See all 114 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 16 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K141911 (Osteonic Co., Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K091679.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112812: Leforte Neuro System Bone Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112812
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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