510(k) · Cleared
ClearedSynthes (Usa) 2.0MM Titanium T-Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Dec 18, 2007 after an 81-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 81 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK072758 Synthes (Usa) 2.0MM Titanium T-PlateSynthes (Usa) · 2007
- Descendant · cites it directly · 5 of its ownK100205 Frontier Devices Neuro SystemFolsom Metal Products, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK212391 MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100205Frontier Devices Neuro SystemFolsom Metal Products, Inc. · 2010 · cites it directly5descendants
- K141911Optimus Neuro SystemOsteonic Co., Ltd. · 2015 · 2 generations on4descendants
- K183352Optimus Neuro SystemOsteonic Co., Ltd. · 2019 · 3 generations on2descendants
- K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019 · 3 generations on1descendant
- K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072758 | Synthes (Usa) 2.0MM Titanium T-Plate | Synthes (Usa) | 2007 | — |
| +1 | K100205 | Frontier Devices Neuro System | Folsom Metal Products, Inc. | 2010 | — |
| +2 | K141911 | Optimus Neuro System | Osteonic Co., Ltd. | 2015 | — |
| +3 | K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019 | — |
| +3 | K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019 | — |
| +3 | K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 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 16.9 · 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? (4)
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 |
|---|---|---|---|
| * | — | Bioplate Rigid Bone Plating System Named without a submission number | |
| * | — | Synthes Titanium Contourable Mesh Plates Named without a submission number | |
| * | — | Synthes Matrix Mandible Reconstruction Plate Named without a submission number | |
| * | — | Synthes Occipital-Cervical Plate Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100205 | Frontier Devices Neuro System | 2010 | 5 |
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?
- Of its descendants, K100205 (Folsom Metal Products, Inc., 2010) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Synthes (USA) 2.0mm Titanium T-Plate is intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skull based approach, with or without duraplasty, including procedures to treat Chiari Type I Malformation. The plate design is also intended for use in non-load bearing fixation, including cranial bone fixation. The device is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072758: Synthes (Usa) 2.0MM Titanium T-Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072758
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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