Germany-based medical device firm joimax has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Percusys percutaneous pedicle screw-rod system.
The patented system is a multi-functional implant, which has been developed for use during spinal stabilization procedures.
Percusys implants include single packaged, sterile, and pre-assembled pedicle screws with lengthening shaft and set-screw.
The company noted that all screws are color coded according to their diameter, cannulated, fenestrated, self-cutting and self-drilling.
The screw and instrument design of the system provides safer and an effective surgical technique with minimal steps for the surgeon and each surgical step is carried out using the lengthening shaft , which is tightly connected to the tulip.
According to joimax, the system can be used in combination with the EndoLIF O-Cage.
Joimax CEO and founder Wolfgang Ries said: "This offers an optimal solution for minimally invasive, endoscopic-assisted access to the intervertebral disc."
The company develops and markets technologies and methods for minimally invasive endoscopic spinal surgery.
Image: joimax has obtained FDA approval for Percusys percutaneous pedicle screw-rod system. Photo: courtesy of joimax/ GlobeNewswire, Inc.