The fixation system, which is designed for several purposes, including sacroiliac fusion to address issues like degenerative sacroiliitis and sacroiliac joint disruptions, features the company’s proprietary NANOACTIV surface technology and is compatible with StealthStation Navigation
FDA gives clearance to Xēnix Medical’s SOLACE Sacroiliac Fixation System. (Credit: Business Wire/Xēnix Medical)
US-based surgical implant company Xēnix Medical has been granted 510(k) clearance from the US Food and Drug Administration (FDA) for the commercialisation of SOLACE Sacroiliac Fixation System.
The fixation system features the company’s proprietary NANOACTIV surface technology. It is compatible with StealthStation Navigation, a medical technology system developed by Medtronic.
According to Xēnix Medical, the SOLACE Sacroiliac Fixation System comprises 3D printed threaded implants with diameters ranging from 10.5mm to 12mm and lengths spanning from 30mm to 115mm.
The implants have NANOACTIV nanotechnology surface and are equipped with helical autograft harvesting flutes and porous channels that facilitate bone ingrowth along the length of the device.
The SOLACE Sacroiliac Fixation System is designed for several purposes, including sacroiliac fusion to address issues like degenerative sacroiliitis and sacroiliac joint disruptions.
It is also intended for augmenting, immobilising, and stabilising the sacroiliac joint in skeletally mature patients as part of lumbar or thoracolumbar fusion procedures.
Additionally, the system can be used for the fixation of fractures involving the sacroiliac joint, whether they are acute, non-acute, or non-traumatic in nature.
The system has also received clearance for guiding the placement of SOLACE implants and instruments that use the Medtronic StealthStation system and NavLock trackers. The combination aids the surgeon in accurately identifying anatomical structures during both open and minimally invasive procedures, said Xēnix Medical.
Xēnix Medical president Ryan Phillips said: “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.
“This system will also provide independent distributors a superior option to compete with the industry leader in this space, which predominantly utilises a direct sales force.”
Last month, Xēnix Medical obtained the FDA’s 510(k) clearance for its neoWave line of interbody fusion implants, incorporating the NANOACTIV surface technology with a nanotechnology designation.