The US Food and Drug Administration (FDA) has granted 510(k) clearance to Xēnix Medical for the marketing of the SOLACE Sacroiliac Fixation System with NANOACTIV technology and compatibility with StealthStationNavigation.
Engineered with nano-scale surface features at a nanometer (10-⁹) level, the NANOACTIV micro and nano-roughened surface helps improve fixation to adjacent bone.
The SOLACE system features 3D-printed, threaded implants ranging from 30mm to 115mm in length and 10.5mm or 12mm in diameter.
Implants also have porous channels and helical autograft harvesting flutes for bony ingrowth along the device’s length.
The system can be used for sacroiliac fusion for sacroiliac joint dysfunction, including sacroiliac joint disruptions and degenerative sacroiliitis.
It also helps in stabilisation, augmenting and immobilisation of the sacroiliac joint in skeletally mature patients who are undergoing sacropelvic fixation as part of a thoracolumbar or lumbar fusion.
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The system is also suitable for fracture fixation of non-acute, acute and non-traumatic fractures involving the sacroiliac joint.
Furthermore, it is approved for SOLACE implants and instrumentation navigation using the Medtronic StealthStation system and NavLocktrackers.
With this approach, the surgeon will be able to accurately locate anatomical structures in either open or minimally invasive procedures.
Xēnix Medical president Ryan Phillips said: “Leveraging our expertise in additive manufacturing, this system opens the door to a new level of opportunity for the company to grow within our current and future distribution channels.
“The SOLACE system is the only nanotechnology sacroiliac fixation system on the market designed specifically for a lateral, oblique or posterior sacral alar iliac technique, giving surgeons complete versatility with a best-in-class technology platform.”