510(k) · Cleared
ClearedSterile NS System
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 Sep 11, 2017 as substantially equivalent to K112812 (Jeil Medical Corporation, 2012) and 1 other predicate after a 217-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Sep 11, 2017
- Review
- 217 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K953806 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 5 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 4 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 3 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 2 generations backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- 1 generation backK141452 Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation · 2014
- This deviceK170368 Sterile NS SystemJeil Medical Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −5 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −4 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −3 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −2 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| −1 | K141452 | Leforte Neuro System Bone Plate and Screw | Jeil Medical Corporation | 2014 | — |
| 0 (this device) | K170368 | Sterile NS System | Jeil Medical Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 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? (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 |
|---|---|---|---|
| * | K112812 | Leforte Neuro System Bone PlateSummary page 4…n of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; • 510(k) Number: K112812, K141452 • Applicant: Jeil Medical Corporation • Common Name: Bone plate &… | 2012 |
| * | K141452 | Leforte Neuro System Bone Plate and ScrewSummary page 4…icate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; • 510(k) Number: K112812, K141452 • Applicant: Jeil Medical Corporation • Common Name: Bone plate & screw… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 3 other devices also cite its predicate K112812.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Sterile NS System 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/K170368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170368: Sterile NS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170368
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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