Device Dossier
MEDPOR Customized Cranial Implant - Prosthesis, internal, ear/nose/throat, synthetic
Device Dossier for MEDPOR Customized Cranial Implant - Prosthesis, internal, ear/nose/throat, synthetic (Prosthesis, internal, ear/nose/throat,…
- GMDN category: Prosthesis, internal, ear/nose/throat, synthetic
- Sponsor: Stryker
Intended purpose
The MEDPOR Customized Implant is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH), in the adult population.
Functional description
The MEDPOR Customized Implant is a customized patient-specific implant for cranial and/or facial application based on CT-data and input by the surgeon. Surgeons supply Stryker with a patient CT scan and the implant is designed to fit the exact patient needs. The implant is designed to fulfil surgeon's requirements and is approved by the requesting surgeon