dimecres, 15 de març del 2017

DJO Global wins FDA 510(k) for Exprt revision hip portfolio

DJO Global

DJO Global said today it won FDA 510(k) clearance for its Exprt revision hip portfolio.

The newly cleared Exprt devices feature anatomically inspired designs with a focus on efficiency and strength, according to the San Diego, Calif.-based company. DJO Global also touted the system as 40-70% of the price of comparable systems.

“Having a thoughtful approach to introducing new technology in today’s healthcare landscape will drive shifts in the market place.  We designed DJO Global’s Exprt revision hip and knee systems to challenge conventional approaches to revision arthroplasty.  These systems allow me to do what I used to think wasn’t possible – treat my patients with a high-quality implant with improved surgical efficiency and reproducible outcomes while simultaneously being economically responsible,” Exprt platform design team member Dr. Michael Taunton of the Mayo Clinic said in a prepared statement.

DJO Global said its 2-tray revision systems result in an 80-90% reduction in instruments compared to other competitive systems, reducing cost, sterilization time and overall operating time.

“One of the biggest challenges our healthcare system encounters is introducing modern technologies at increased price points.  The latest addition to the Exprt portfolio signifies our deep commitment to not only clinical outcomes, but both surgical and cost efficiencies,” DJO Global surgical division senior VP Mark Russell said in a press release.

Earlier this week, DJO Global said it launched its AltiVate anatomic shoulder system, featuring a short, bone sparing humeral stem anatomically designed through morphologically-based fit analysis meant to optimize metaphyseal fit and stability.

The company said the system’s stem also features the company’s proprietary D2 porous coating to allow for bone ingrowth. The unit also includes a glenoid component with the companies “Drop and Go” technology designed for immediate fixation.

The post DJO Global wins FDA 510(k) for Exprt revision hip portfolio appeared first on MassDevice.



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