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The JACE Medical Thoracic Plating System is indicated for use in the stabilization and fixation of fractures of the chest wall including sternal fixation following stemotomy and sternal reconstructive surgical procedures, trauma, or planned osteotomies.

The JACE Medical Thoracic Plating System consists of plates and accessories designed to provide fixation following sternotomy and sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system includes instrumentation which has been specifically designed for use with this system of implant. The system is comprised of an assortment of various plate configurations, locking screws, and accompanying instrumentation. Variants of the plates include flat and pre-contoured concave and convex plates. Plates may be bent to fit patient anatomy. Plates are secured using previously cleared JACE self-drilling locking bone screws (K142484), which are offered in a single diameter of 3.5mm and have a range of lengths from 10mm to 20mm. There are no changes to the screws and they are not within the scope of this 510(k). Like the predicate device, all implant components are manufactured from titanium alloy (Ti-6-Al-4 ELI) per ASTM F136. All implants in the JACE Medical Thoracic Plating System are intended for single use only. The plates, screws, and all associated instrumentation will be provided nonsterile, to be steam sterilized by the end user. MR compatibility has been established.