Device Dossier

Medicrea PASS - Bone-screw internal spinal fixation system, non-sterile

Device Dossier for Medicrea PASS - Bone-screw internal spinal fixation system, non-sterile (Bone-screw internal spinal fixation system, non-sterile,…

Intended purpose

The PASS systems (PASS TL, PASS LP) are pedicle screw fixation systems for the thoracolumbar spine. PASS LP is cleared for use in skeletally mature patients. This top loading, side connecting system allows for connection to the rod at a distance from the spine. Controlled spondylolisthesis reduction is achieved by a powerful, gentle rod reduction onto the screw-posts and by using offset screws. The PASS LP system is comprised of pedicle screws, sacral plates, rod-plates and connectors made of Titanium Alloy (Ti-6AI-4V). Rods are offered both in Titanium Alloy and Cobalt Chrome (CoCr).

TGA Public Summary