510(k) · Cleared
ClearedStryker Universal Neuro 3 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jan 5, 2012 as substantially equivalent to K031659 (Stryker Instruments, 2003) and 4 other predicates after a 125-day review. Its family tree reaches back 6 generations to 1976. 9 later devices descend from it.
- Decided
- Jan 5, 2012
- Review
- 125 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K761228 (1976). 29 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 5 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 4 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 3 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 2 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- 1 generation backK031659 Universal Neuro SystemStryker Instruments · 2003
- This deviceK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- Descendant · cites it directly · 4 of its ownK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS…Stryker · 2015
- Descendant · 2 generations on · 2 of its ownK140309 CranioplugOssdsign AB · 2014
- Descendant · 3 generations on · 1 of its ownK181539 OSSDSIGN CranioplugOssdsign AB · 2018
- Descendant · 2 generations on · 1 of its ownK171152 Stryker Universal Neuro III System AXS ScrewStryker · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120352Stryker Quikflap Sterile Procedure PackStryker · 2012 · cites it directly4descendants
- K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker · 2015 · cites it directly2descendants
- K140309CranioplugOssdsign AB · 2014 · 2 generations on2descendants
- K181539OSSDSIGN CranioplugOssdsign AB · 2018 · 3 generations on1descendant
- K171152Stryker Universal Neuro III System AXS ScrewStryker · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −5 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −2 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| −1 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| 0 (this device) | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| +1 | K120352 | Stryker Quikflap Sterile Procedure Pack | Stryker | 2012 | 18 |
| +1 | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver… | Stryker | 2015 | — |
| +2 | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| +3 | K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018 | — |
| +2 | K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K031659 | Universal Neuro SystemSummary page 3…ded by Stryker in this 510(k) application was found to be substantially equivalent with these predicate devices: * Stryker Universal Neuro, 2 System (Stryker, K03 1659) * Stryker Micro Dynamic Mesh (Stryker, K983 528) * Synthes Neuro Plate and Screw System (Synthes, K022012)… | 2003 |
| * | K983528 | Micro Dynamic MeshSummary page 3…bstantially equivalent with these predicate devices: * Stryker Universal Neuro, 2 System (Stryker, K03 1659) * Stryker Micro Dynamic Mesh (Stryker, K983 528) * Synthes Neuro Plate and Screw System (Synthes, K022012) * KLS-Martin Micro Osteosynthesis… | 1998 |
| * | K022012 | Synthes Low Profile Neuro SystemSummary page 3…ker Universal Neuro, 2 System (Stryker, K03 1659) * Stryker Micro Dynamic Mesh (Stryker, K983 528) * Synthes Neuro Plate and Screw System (Synthes, K022012) * KLS-Martin Micro Osteosynthesis System (KLS-Martin, K944561/K944565) The Stryk… | 2002 |
| * | K944561 | Micro Osteosynthesis System (1.0)Summary page 3…* Synthes Neuro Plate and Screw System (Synthes, K022012) * KLS-Martin Micro Osteosynthesis System (KLS-Martin, K944561/K944565) The Stryker Universal Neuro 3 System, as stated above, consists of devices with three product codes: OWO (plates), GXR… | 1994 |
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 3…* Synthes Neuro Plate and Screw System (Synthes, K022012) * KLS-Martin Micro Osteosynthesis System (KLS-Martin, K944561/K944565) The Stryker Universal Neuro 3 System, as stated above, consists of devices with three product codes: OWO (plates), GXR (burr ho… | 1994 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120352 | Stryker Quikflap Sterile Procedure Pack | 2012 | 4 |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | 2015 | 2 |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | 2020 | 0 |
| K131775 | Universal Neuro 3 System | 2013 | 0 |
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 36 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K120352 (Stryker, 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K031659.
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?
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non-load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112557: Stryker Universal Neuro 3 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112557
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