Pediatric Plating Platform Hip

The Pediatric Plating Platform | Hip is a system of metallic bone plates, screws, and connector bolts in various sizes for temporary internal fixation and stabilization of proximal femur fractures, osteotomies, mal-unions, and non-unions in pediatric and small stature adult patients. It is manufactured from 316LVM stainless steel and includes surgical instruments, with plates available in multiple angles and offsets to accommodate different anatomies.

The device is substantially equivalent to the predicate Locking Proximal Femur System in intended use and principle of operation. There are some differences in design and size options between the subject and predicate devices, but these differences do not raise new safety and effectiveness questions.

ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119 (for MR Environment evaluation); ASTM F543 (Axial Pullout Strength); ASTM F384 (Static Compression Bending and Fatigue). Biocompatibility assessment based on prior use of the predicate device sharing the same materials, manufacturing processes, geometry, and clinical use.

The subject device shares the same intended use (temporary internal fixation of proximal femur fractures and osteotomies) and principle of operation as the predicate Locking Proximal Femur System. Both devices use the same material (316LVM stainless steel), manufacturing and cleaning processes, geometry, and body contact characteristics. The predicate device's established biocompatibility and mechanical performance provide the foundation for equivalence, with successful testing data demonstrating that design and size option differences do not introduce new safety or effectiveness concerns.