# K072758: Synthes (Usa) 2.0MM Titanium T-Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 18, 2007 after 81 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bioplate Rigid Bone Plating System: named in the summary without a submission number
- (no number) Synthes Titanium Contourable Mesh Plates: named in the summary without a submission number
- (no number) Synthes Matrix Mandible Reconstruction Plate: named in the summary without a submission number
- (no number) Synthes Occipital-Cervical Plate: named in the summary without a submission number

## Most influential descendants
- K100205: Frontier Devices Neuro System (2010), 5 descendants of its own
- K141911: Optimus Neuro System (2015), 4 descendants of its own
- K183352: Optimus Neuro System (2019), 2 descendants of its own
- K190811: Optimus NEURO System - Sterile Kit (2019), 1 descendant of its own
- K212391: MCI-Neuro Fixation System (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K072758
Methodology: https://510kreport.com/methodology