TriMed Fusion Cup System

The TriMed Fusion Cup System is a bone fixation device used to treat small bone arthrodesis in the midfoot and wrist/hand. It consists of fusion cups manufactured from implantable medical-grade polyetheretherketone (PEEK) and polyaxial locking of screws, designed to be used with TriMed 2.4mm compression screws made of Ti6Al-4V ELI. The device comes in multiple size configurations to accommodate different patient anatomies and surgical sites.

The TriMed Fusion Cups utilize the same design philosophy and materials as the predicate device (Easy Lock Osteosystem with Xtremities Plates). The new system offers additional size configurations for fusion cups and compression screws. Key differences include PEEK cups with larger diameter screws and screw holes compared to a smaller diameter PEEK cup variant, and Ti6Al-4V ELI compression screws that meet specified performance standards.

ASTM F543 testing was performed on the screws. Static and endurance construct compression testing was performed on the PEEK cups. The device evaluation followed FDA Guidance on 'Orthopedic Non-Spinal Metallic Bone Screws and Washers — Performance Criteria for Safety and Performance Based Pathway.'

The TriMed Fusion Cups are substantially equivalent because they employ the same design philosophy, materials (PEEK and Ti6Al-4V ELI), and operational principles as the predicate Easy Lock Osteosystem. The changes consist only of offering additional size configurations and variations in screw hole diameter and cup diameter, which do not introduce new safety or efficacy risks. Design control verification testing demonstrated that the new configurations meet the same performance requirements as the predicate, and the indications for use remain within the established scope of small bone arthrodesis.