SIG Medical said this week it won FDA 510(k) clearance for its AdvantageRib anterior system, a rib fracture system.
The newly cleared AdvantageRib anterior system includes anatomically contoured titanium plates intended to closely fit patient anatomy and screws, and is intended to be used through a traditional anterior approach. The system also features straight plates to allow the surgeon to create a construct to fit challenging clinical scenarios.
“We are thrilled to have achieved this approval and now have the most comprehensive portfolio of rib fracture products. The AdvantageRib family of products is truly revolutionary and will change how suffering patients are treated. Surgeons now have choices as to how best to treat their patients, in both a traditional manner or with our novel system that is on the forefront of improving how rib fractures are managed. Today is a huge leap for us and the medical community as a whole,” product dev & marketing VP Andrew Davison said in prepared remarks.
Screws included with the system include self-drilling, self-tapping, locking and non-locking screws in a range of different sizes to fit varying anatomy, SIG Medical said.
“We have a world class team, working capital, and now the most complete line of products to lead the market in fixing fractured ribs. The AdvantageRib family of products will have a significant impact on the algorithm of care for decades to come and I am proud to be part of such an exciting movement,” prez & CEO Ken Kremer said in a press release.
The device is the second rib fracture system that the Hershey, Penn.-based company is commercializing, according to a press release.
