Device Dossier
PEEK Customized Implants - Cranioplasty plate, non-alterable
Device Dossier for PEEK Customized Implants - Cranioplasty plate, non-alterable (Cranioplasty plate, non-alterable, Class III, sponsor Stryker). ARTG…
- GMDN category: Cranioplasty plate, non-alterable
- Sponsor: Stryker
Intended purpose
PEEK Customized implants are indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 12 years of age and older.
Functional description
The PEEK Customized Implant is a customized patient specific implant based on CT-data and input by the surgeon. The implant is fabricated from polyetheretherketone (PEEK) and is intended to be used to fill bony voids in the cranial skeleton or craniofacial region.