Distal Xtremities System

The TriMed Distal Xtremities System is a bone fixation device consisting of 2.0mm and 2.3mm locking screws and six new titanium plate configurations designed to stabilize fractures, malunions, and nonunions of small bones in the foot. The plates vary in hole count and geometric profile (straight and T-shaped) to accommodate different anatomical needs.

The Distal Xtremities System uses titanium alloy plates without PEEK inserts, unlike the predicate Easy Lock Osteosystem which incorporates both titanium alloy and PEEK materials. The new system includes additional plate sizes and different dimensional configurations (number of screw holes, plate thickness, and lengths) compared to the predicate.

Not stated in this summary.

The screws are substantially equivalent because theoretical calculations and retrospective review of existing TriMed physical testing data demonstrate the new 2.0 and 2.3mm screws do not create a new worst-case scenario within TriMed's established screw families, eliminating the need for new physical testing. FEA (finite element analysis) analysis confirms that dimensional differences and the material change from PEEK/titanium to titanium-only does not negatively impact mechanical performance of the plates, and implant materials are identical to those in previously FDA-cleared TriMed products with established biocompatibility.