XĒNIX MEDICAL


Associated tags: Nanotechnology, MD, Medical device, Patient, Surgery, Regulation of tobacco by the U.S. Food and Drug Administration, Stem cell, Food, Health, Medical Devices, FDA, Associate, Biomedicine, The King of Fighters Neowave, Arthrodesis, Pennsylvania State University, Subsidence, Biomedical engineering, 3D, Incidence

Locations: FLORIDA, UNITED STATES, NORTH AMERICA

Xēnix Medical Receives FDA Clearance of SOLACE™ Sacroiliac Fixation System with NANOACTIV™ Nanotechnology

Retrieved on: 
Tuesday, October 31, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231031697414/en/
    Xenix Medical SOLACE Sacroiliac Fixation System (Photo: Business Wire)
    The SOLACE Sacroiliac Fixation System consists of 3D printed, threaded implants ranging 10.5mm or 12.0mm in diameter and 30mm to 115mm in length.
  • The SOLACE Sacroiliac Fixation System is intended for sacroiliac fusion for sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions; augmenting, immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion; and for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
  • The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.
  • 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.

Xēnix Medical neoWave™ Interbody Systems Receive FDA Clearance for NANOACTIV™ Nanotechnology Surface

Retrieved on: 
Tuesday, October 10, 2023

The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.

Key Points: 
  • The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.
  • Ryan Phillips, President of Xēnix Medical, commented, “Receiving nanotechnology clearance for the neoWave interbody systems is an incredible milestone and achievement for Xēnix, elevating the neoWave implant systems into a distinct device category shared only by a few companies in the industry.
  • As we actively develop a complete line of neoWave interbody devices, the NANOACTIV surface will be a dominant enhancement of future implant systems.
  • The unique combination of a nanotechnology surface and completely latticed implant presents a significant breakthrough in treating patients that require interbody fusion.