# K243715: Synthes Patient Specific Implants

- Pathway: 510(k) (Traditional)
- Applicant: Synthes GmbH
- Decided: Nov 12, 2025 after 345 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: 5 generations back to K904111 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220357: MedCAD AccuShape Titanium Patient-Specific Cranial Implant, Medcad (2022) Summary page 5.

## Indications for use
Patient Specific Implants are intended for the replacement of bony voids in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

Source page: https://510kreport.com/device/K243715
Methodology: https://510kreport.com/methodology