510(k) · Cleared
Recalled · Class II · 2023Osteomed Low Profile Neuro Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Aug 15, 2011 as substantially equivalent to K911936 (Osteomed Corp., 1991) and 1 other predicate after a 110-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 15, 2011
- Review
- 110 days
- Class
- Class II
- Product code
- GWO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911936 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911936 | Osteomed SBF System (SBF) | Osteomed Corp. | 1991 | — |
| 0 (this device) | K111176 | Osteomed Low Profile Neuro Fixation System | Osteomed LP | 2011 | — |
| +1 | K141123 | Alliance Spine Raas Cranial Plating System | Alliance Partners, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K911936 | Osteomed SBF System (SBF)Summary page 1…Device Class: 2 510(k): K111176 Predicate Devices: OsteoMed SBF system. K91 1936 Classification Name: lntraosseous fixation screw or wire (2ICFR 872.4880,… | 1991 |
| * | K924138 | Osteomed M3 System (SBF System)Summary page 1…Product Code DZL) Device Class: 2 OsteoMed M3 SBF system (Addendum). K924138 Classification Name: Bone Plate (21CFR 872.4760, Product Code JEY) Device… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141123 | Alliance Spine Raas Cranial Plating System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2023 | Class II | Z-2107-2023 | Nonconforming Material/Component | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
| May 31, 2023 | Class II | Z-2108-2023 | Nonconforming Material/Component | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 OSTEOMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones.
Implants and drills are single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111176: Osteomed Low Profile Neuro Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111176
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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