510(k) · Cleared
ClearedInnovasis Cranial System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Nov 7, 2014 as substantially equivalent to K112812 (Jeil Medical Corporation, 2012) after a 141-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Nov 7, 2014
- Review
- 141 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953806 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 4 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 3 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 2 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 1 generation backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- This deviceK141644 Innovasis Cranial SystemInnovasis, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −4 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −3 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −2 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −1 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| 0 (this device) | K141644 | Innovasis Cranial System | Innovasis, Inc. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K112812 | Leforte Neuro System Bone PlateSummary page 4…Regulation No.: 21 CFR 882.5250 Class 2, Product Code: GXR III. Predicate Device Jeil Medical Products LeForté Neuro System Bone Plate K112812 This predicate has not been subject to a design-related recall. IV. Device Description: The Innovasis Cranial System B… | 2012 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 8 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. 2014, 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 Innovasis Cranial System is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141644: Innovasis Cranial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141644
Report an extraction error
Are you the manufacturer?
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