(148 days)
The Biomet Microfixation Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.
The Biomet Microfixation Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
The provided document is a 510(k) summary for the Biomet Microfixation Thoracic Fixation System, which is a medical device for stabilizing chest wall fractures. It explicitly states that no non-clinical or clinical performance data was necessary for the determination of substantial equivalence. Therefore, the document does not contain information regarding acceptance criteria or a study proving the device meets those criteria.
The submission relies on claims of substantial equivalence to predicate devices (K121302, Biomet Microfixation Sternal Closure System and K133616, Synthes MatrixRIB Plating System) based on similarities in intended use, materials, and design principles.
As such, I cannot provide the requested information from this document.
§ 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.