SMART Osteotomy System

The SMART Osteotomy System consists of anatomically shaped titanium plates and bone screws designed to stabilize osteotomy gaps in the proximal tibia and distal femur. The plates are implanted on the bone surface and secured with locking and non-locking screws to maintain correction angle until bone union occurs. It is intended for skeletally mature patients undergoing open or closed wedge osteotomies to treat bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

The subject device uses medical-grade titanium alloy plates and screws with similar material composition, principles of operation, and system components as the predicate. Both are provided sterile via gamma radiation and are single-use devices. Minor differences include different shaped plate heads and slightly smaller plate dimensions in the subject device (e.g., 103 mm vs. 141 mm length for lateral distal femur plates), but both accommodate 4.5 mm diameter screws in similar length ranges.

The device was tested to biocompatibility evaluation per ISO 10993-1, sterilization validation, mechanical testing per ASTM F543 and ASTM F382, cleaning validation for reusable instruments, usability, stability/shelf life, MRI evaluation, and packaging testing.

The SMART Osteotomy System is substantially equivalent to the DePuy Synthes TOMOFIX Osteotomy System (K141796) based on identical indications for use, material composition, system components, configurations, classification, sterility method, single-use status, and principles of operation. Both are Class II metallic bone fixation appliances (21 CFR 888.3030, product code HRS) designed to bridge osteotomy gaps with plates and locking/non-locking screws. The minor dimensional and head-shape differences do not impact the safety or effectiveness of the devices.