joimax receives 510(k) clearance for Percusys pedicle screw-rod system


joimax has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Percusys percutaneous pedicle screw-rod system.

The Percusys system is a multi-functional implant for use during spinal stabilisation procedures. Joimax says that its screw and instrument design enables 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.

“During development, the main focus was on the ease-of-use of the system,” says Frank Hassel, specialist for spine surgery from Freiburg, Germany, who was instrumental in Percusys’ development. “The idea was to reduce the complexity in instrumentation and simplify stabilisation procedures to minimise the potential damage of soft tissues and improve overall patient outcomes.”

Percusys implants comprise single-packaged, sterile, and pre-assembled pedicle screws with lengthening shaft and set-screw. All screws are colour-coded according to their diameter, cannulated, fenestrated, self-cutting and self-drilling. Each surgical step is carried out using the lengthening shaft, which is tightly connected to the tulip. 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.

The company also notes that Percusys can be used in combination with joimax’s EndoLIF O-Cage. “This offers an optimal solution for minimally invasive, endoscopic-assisted access to the intervertebral disc,” says Wolfgang Ries, chief executive officer and founder of joimax. “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.”