Rapid Resorbable Fixation System
The Rapid Resorbable Fixation System is primarily intended for treatment of pediatric patients suffering from craniosynostosis which causes premature skull fusion, resulting in impeded skull growth, and increased intracranial pressure. The Rapid Resorbable Fixation System can also be used in non-load bearing applications such as maintaining the relative position of and/or containing bony fragments, bone grafts or bone graft substitutes in reconstruction or mandibular areas. The Rapid Resorbable Fixation System consists of a complete line of plates, meshes, sheets, and screws in a faster-resorbing polymer [85:15 poly (L-lactide-co-glycolide)]. The polymer resorbs within approximately twelve months by bulk degradation and hydrolysis without the late inflammatory complications and foreign body responses observed with semi-crystalline structures. The polymer strengths are not affected by radiation therapy. A variety of shapes and sizes is available. Additional shaping to the contours of the anatomy is possible by heating or cutting to the desired shape. The instrumentation, eg, in situ Bender/Cutter of the existing Resorbable Fixation System can be used. The Resorbable Screws come in thread diameters of 1.5, 2.0 and 2.5 mm and lengths of 3.0 to 8.0 mm. The Resorbable Plates offer screw diameters of either 1.5 or 2.0 mm. The plate thickness varies from 0.5, 0.8 to 1.2 mm. They come in the following shapes: straight, adaption, orbital rim, orbital floor, oblique-L, Y, X, strut, and burr-hole cover. The Resorbable Meshes are available in 0.25, 0.5, 0.8, and 1.2 mm thickness, and either square, round, or crescent shape.
Bending Templates
Bending Templates for the different plates of the Resorbable Fixation System are now also available in stainless steel. These Bending Templates are much more stable than the existing ones in titanium. They can be bent several times without breaking. The Bending Templates are available for the 1.5 and 2.0 mm Adaption Plate with 8 and 20 holes, 1.5 mm Strut Plate with 20 and 36 holes, 2.0mm Strut Plate with 20 holes, 1.5 and 2.0 mm L- Plate with 10 holes, 1.5 and 2.0 mm Y-Plate with 10 holes, 1.5 mm Double-Y-Plate with 10 holes, 1.5 and 2.0 mm Orbital Plate with 10 holes, and the 1.5/2.0 mm Mesh Plates.
Rapid Resorbable Tack and 1.7 mm Emergency Rapid Resorbable Tack
The Resorbable Tack System was developed to provide surgeons with a means for fast and simple fixation of resorbable plates to the bone. The resorbable tacks feature circumferential ribs which provide interference fit against bone when tacks are press-inserted into predrilled holes. The simple drill and push insertion is a time saving means of 1.5 mm rapid resorbable tack, 6 mm plate fixation. This tack line extension is manufactured from 85:15 poly (L-lactide-co-glycolide) as are all other implants in the rapid resorbable fixation system. It is available as 1.5 mm regular plus 1.7 mm emergency version, and compliments the screw options currently available. The existing instrumentation is utilized.
Hazards and labeling
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