510(k) · Cleared
ClearedAlliance Spine Raas Cranial Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Partners, LLC · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Feb 27, 2015 as substantially equivalent to K031659 (Stryker Instruments, 2003) and 1 other predicate after a 302-day review. Its family tree reaches back 6 generations to 1976.
- Decided
- Feb 27, 2015
- Review
- 302 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K761228 (1976). 29 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK141123 Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC · 2015
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) | K141123 | Alliance Spine Raas Cranial Plating System | Alliance Partners, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 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 |
|---|---|---|---|
| * | K031659 | Universal Neuro SystemSummary page 4…ner Product Codes: GWO, GXR, HBW (a)(3) Predicate Devices: Stryker-NEURO II (K031659) OsteoMed-Low Profile Neuro (K111176) (a)(4) Device Descrip… | 2003 |
| * | K111176 | Osteomed Low Profile Neuro Fixation SystemSummary page 4…e Devices: Stryker-NEURO II (K031659) OsteoMed-Low Profile Neuro (K111176) (a)(4) Device Description: The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries… | 2011 |
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 39 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 29 ancestors have a recall of any class.
- 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. 2015, 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 Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, craniotomy, cranial fractures, and reconstruction of non-load bearing cranial areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141123: Alliance Spine Raas Cranial Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141123
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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