510(k) · Cleared
ClearedNeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovention, LLC · GXR Cover, Burr Hole
Cleared on Mar 13, 2020 as substantially equivalent to K112557 (Stryker, 2012) after a 217-day review. Its family tree reaches back 7 generations to 1976.
- Decided
- Mar 13, 2020
- Review
- 217 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K761228 (1976). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 3 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- 2 generations backK031659 Universal Neuro SystemStryker Instruments · 2003
- 1 generation backK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- This deviceK192162 NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole…Neurovention, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −6 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −3 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| −2 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| −1 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| 0 (this device) | K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC… | Neurovention, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 GXR? 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 GXR device
- #1 K253447 Montage Flowable Settable, Resorbable Bone…score 13.7 · 10 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 |
|---|---|---|---|
| * | K112557 | Stryker Universal Neuro 3 SystemSummary page 4…Product Code GXR, GWO, HBW, HBG Predicate Device Name 510(k) Number Manufacturer Stryker Universal Neuro 3 System K112557 Stryker Description The NeuroVention Cranial Fixation System is a series of burr hole covers and… | 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 44 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 30 ancestors have a recall of any class.
- 3 other devices also cite its predicate K112557.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GXR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXR
116in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXR
No recall names GXR since 2007.
Adverse event reports per year · GXR
10in 2025
MAUDE reports naming product code GXR, 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 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 4 | 116 | 0 | 4 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 45 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 2 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following
craniotomy, cranioplasty, or craniectomy surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192162 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192162: NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192162
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