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The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

The Synthes (USA) Modular Blade Plate System is comprised of a spiral blade that attaches to one end of a side plate, secured with a coupling screw to create a fixed angle construct. The Modular Plates are available in various configurations - 90°, 110°, 120° and 130° plates with off-sets, and 95° or 130° plates without off-sets. The Modular Plates have standard locking-compression holes (LCP) in the shaft and are available in a variety of lengths to accommodate varying injury, patient anatomy and size. The Modular Plates are available to be used with 4.5 mm Cortex screws or 5.0 mm Locking screws. The Spiral Blades rotate 90° clockwise or counterclockwise over the length of the blade. A variety of lengths are available to accommodate varying patient anatomy. The coupling screw is one size fits all plate and blade configurations.

This document is a 510(k) summary for the Synthes (USA) Modular Blade Plate System. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this submission does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The provided text from K080109 mainly consists of:

• 510(k) Summary: Manufacturer contact, device name, classification, predicate device, device description, and intended use.
• FDA Letter: Formal notification from the FDA regarding the 510(k) clearance, confirming substantial equivalence and outlining regulatory responsibilities.
• Indications for Use Form: A standard FDA form reiterating the intended use of the device.

There is no mention of performance data, clinical trials, or any studies designed to establish acceptance criteria or demonstrate the device's efficacy or safety against such criteria. The FDA clearance is based on substantial equivalence to a predicate device, meaning it is deemed as safe and effective as a legally marketed device, not necessarily on performance against specific, pre-defined acceptance criteria demonstrated through a new study.

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