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The Synthes 4.5 mm Titanium LCP Proximal Tibia System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.

The Synthes Titanium 4.5mm LCP Proximal Tibia Plating System consists of 4.5 mm Titanium LCP Proximal Tibia Plates, 5.0 mm Titanium Cannulated Locking and Conical screws, and 4.0 mm and 5.0 mm Titanium Solid Locking screws . The Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. These are plates designed for either the right or left tibia in a variety of shaft lengths. The plate head has threaded screw holes and 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures. The plate shaft has combination screw holes (dynamic compression and locking screw holes), that accept 4.5 mm cortex, 6.5 mm cancellous, 5.0 mm cannulated locking, 5.0 mm conical, and 4.0 mm & 5.0 mm locking screws. A titanium screw nut is also utilized with this system.

This document is a 510(k) premarket notification for a medical device (Synthes 4.5 mm Titanium LCP Proximal Tibia Plating System). It does not contain information about acceptance criteria or a study proving the device meets those criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting new clinical study data with specific acceptance criteria as would be found in a PMA (Premarket Approval) submission or a clinical trial report.

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