(75 days)
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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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.