TriMed® Compression Screws

TriMed® Compression Screws are cannulated compression screws made of medical-grade stainless steel and titanium. Small screws are used for fracture fixations, non-unions, and osteotomies of small bones in the hand, wrist, elbow, ankle, and foot; large screws serve the same purposes for large bones and bone fragments.

TriMed Compression Screws are manufactured from both stainless steel and titanium alloy, whereas earlier TriMed predicate devices used only titanium alloy. Compared to the DePuy Synthes secondary predicate, the device introduces new screw diameters and lengths while maintaining the same fundamental cannulated compression screw design, principles of operation, and manufacturing approach.

Mechanical testing conducted per ASTM F543-17 (FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway) and comparison testing against compression screws cleared under predicates K050681 and K093676. Design change validation includes IEC 62366-1.

The device does not raise different questions of safety and effectiveness because it maintains identical design features, principles of operation, manufacturing methods, packaging, and labeling as the predicates. The introduction of stainless steel as an additional material option and new screw diameters/lengths are supported by testing against the DePuy Synthes secondary predicate (K161616), which already demonstrates clearance with material and size variations. All differences are characterized as minor modifications that do not affect safety or effectiveness.