APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista

The APS Osteotomy Fixation System is a titanium-based bone fixation device comprising locking plates and screws designed for correction of knee deformities through osteotomy procedures of the distal femur and proximal tibia. The system includes 4.5mm cortical screws for high-strength fixation and 5.0mm locking screws for angular stability, paired with specialized locking plates for medial and lateral approaches.

The APS system is manufactured from titanium alloy materials comparable to the predicate device. Both the 4.5mm cortical screws and 5.0mm locking screws feature mechanical designs that provide stable screw-plate interface fixation. The locking plates incorporate angle-stable design principles to reduce screw loosening and maintain structural integrity during osteotomy procedures.

Mechanical testing was conducted per ASTM F382 for bone plates and ASTM F543 for bone screws. These tests evaluated bending stiffness, structural integrity, screw strength, and insertion/removal torque characteristics.

The APS Osteotomy Fixation System is substantially equivalent to the predicate Synthes TomoFix Osteotomy System based on identical indications for use (fixation during osteotomy of the distal femur and proximal tibia), comparable titanium alloy materials, and equivalent mechanical performance demonstrated through ASTM-standardized testing that matched predicate device results.