Using micro implants smaller than a dime to treat painful regions of the spine, ION 3D is 30mm-40mm smaller than traditional pedicle screws. The implant transfixes through the facet joint to stabilize the spine.
The Nanotex surface technology is a manufacturing technique developed with osteointegration in mind. The technology allows for controlled pore sizes that help to hold BMA & other fluids that may contain key growth factors.
Most often performed in an outpatient surgery center, it was designed with safety in mind and to help provide patients with a less invasive solution than traditional spine surgery.
Hydrophilic surface created by Nanotex® technology takes advantage of ionic bonds to attract and hold BMA, and other fluids necessary for osteointegration.
INDICATIONS FOR USE/INTENDED USE
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2- S1 (inclusive) spinal levels for the following: Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous fusions which are symptomatic, and Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability.
The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
Ovine spine study at three (3) months revealed
mature bone formation to Nanotex® surface with no
delamination
This information is based on an animal study of the Ion 3D device, and may not be representative of clinical performance
The hydrophilic surface created by Nanotex® technology takes advantage of ionic bonds to attract and hold blood, BMA, and other fluids that may contain key growth factors necessary for osseointegration
The above claim is based on an animal study and may not be representative of clinical performance1