Scandius' tibial fixation system:
This article was originally published in Clinica
Executive Summary
The US FDA has given Scandius BioMedical 510(k) clearance to market its TriTis tibial fixation system for soft tissue anterior cruciate ligament (ACL) reconstruction. The implant was developed to address the problem of fixation strength in the tibia where bone quality is softer, and stronger fixation is needed to hold a soft tissue graft in place, according to the Littleton, Massachusetts firm. The TriTis device is designed to provide improved tibial fixation with a locking device that will prevent implant motion and provide increased pull-out strength, the company said.