# K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate

- Pathway: 510(k) (Traditional)
- Applicant: Bioarchitects USA, LLC
- Decided: Nov 20, 2015 after 150 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: 2 generations back to K832283 (1984). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 4.

## Most influential descendants
- K253116: 3D MAC Titanium Cranial Plate (TCP) System (2026), 0 descendants of its own
- K252251: Easymade-TI (2026), 0 descendants of its own

## Indications for use
The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is intended 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). It is a patient specific device.

Source page: https://510kreport.com/device/K151692
Methodology: https://510kreport.com/methodology