# K253116: 3D MAC Titanium Cranial Plate (TCP) System

- Pathway: 510(k) (Traditional)
- Applicant: The Surgeon General, Department of the Army (TSG-DA)
- Decided: Jun 18, 2026 after 267 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K832283 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate, Bioarchitects USA, LLC (2015) Summary page 5.

## Indications for use
The 3D MAC Titanium Cranial Plate (TCP) System is a patient-specific device that is indicated for use to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer).

Source page: https://510kreport.com/device/K253116
Methodology: https://510kreport.com/methodology