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OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial. Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial. Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile. Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.