German MIS spine device company joimax®, tells us it has received U.S. FDA 510(k) clearance for its Percusys® percutaneous pedicle screw-rod system.
Founded in Karlsruhe, Germany, in 2001, joimax established a U.S. subsidiary Irvine, California, in 2005. The company is primarily focused on the development, production and marketing of technologies and methods for minimally invasive endoscopic spinal surgery.
joimax’s patented Percusys system is a multi-functional implant for use during spinal stabilization procedures. Its unique screw and instrument design leads to the company claiming a safer and more effective surgical technique with minimal steps for the surgeon. The single, small instrument set allows flexibility to perform surgery through a percutaneous, minimally invasive or open approach.
Percusys implants comprise single packaged, sterile, and pre-assembled pedicle screws with lengthening shaft and set-screw. All screws are color coded according to their diameter, cannulated, fenestrated, self-cutting and self-drilling. The assembly allows for direct manipulation and does not require additional instrumentation. Shearing off the lengthening shaft can be done by a 360-degree rotation of the shaft breaker.
“During development, the main focus was on the ease-of-use of the system,” says Dr. Frank Hassel, specialist for spine surgery from Freiburg, Germany, who was instrumental in the Percusys development. “The idea was to reduce the complexity in instrumentation and simplify stabilization procedures to minimize the potential damage of soft tissues and improve overall patient outcomes.”
Percusys can be used in combination with the joimax® EndoLIF® O-Cage, which Wolfgang Ries, joimax CEO and founder says; “…offers an optimal solution for minimally invasive, endoscopic-assisted access to the intervertebral disc.”
“Percusys® represents the next logical step in the development of endoscopic surgery and further strengthens the joimax position as an expert in this special market segment.”
Source: Globe Newswire