# K220357: MedCAD AccuShape Titanium Patient-Specific Cranial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Medcad
- Decided: Aug 26, 2022 after 199 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: 4 generations back to K904111 (1990). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110684: Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant, Vanduzen Dba Medcad (2011) Summary page 4.
- K053199: Synthes Patient Specific Cranial/Craniofacial Implant, Synthes (Usa) (2005) Summary page 4.

## Most influential descendants
- K252251: Easymade-TI (2026), 0 descendants of its own
- K243715: Synthes Patient Specific Implants (2025), 0 descendants of its own

## Indications for use
The MedCAD AccuShape Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

Source page: https://510kreport.com/device/K220357
Methodology: https://510kreport.com/methodology