510(k) · Cleared
ClearedStryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · HBW Fastener, Plate, Cranioplasty
Cleared on Jun 24, 2015 as substantially equivalent to K112557 (Stryker, 2012) after a 29-day review. Its family tree reaches back 7 generations to 1976. 2 later devices descend from it.
- Decided
- Jun 24, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- HBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K761228 (1976). 30 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS…Stryker · 2015
- Descendant · cites it directly · 1 of its ownK171152 Stryker Universal Neuro III System AXS ScrewStryker · 2017
- Descendant · 2 generations on · 0 of its ownK231208 Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023
Most influential descendants
Showing 2 of 2 · See allView 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) | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver… | Stryker | 2015 | — |
| +1 | K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | 2017 | — |
| +2 | K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 HBW? 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 HBW device
- #1 K251472 Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation…score 10.0 · 2 generations · no Class I recall
- #2 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 5…ion 5 System III. PREDICATE DEVICE Predicate: Stryker Universal Neuro III System – K112557 This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Stryker Universal Neuro III System… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171152 | Stryker Universal Neuro III System AXS Screw | 2017 | 1 |
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 39 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K171152 (Stryker, 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K112557.
How does its category compare?
All HBW devicesHBW Fastener, Plate, Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HBW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBW
Too few HBW 510(k)s in any year since 2007 to give a median.
Recalls per year · HBW
No recall names HBW since 2007.
Adverse event reports per year · HBW
3in 2025
MAUDE reports naming product code HBW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker Universal Neuro III 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 as stated in the FDA summary.
https://510kreport.com/device/K151387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151387: Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151387
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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