Kuros Biosciences treated the first patient in a prospectively designed, randomized controlled U.S. trial named PROOF, comparing MagnetOs Putty to autograft for posterolateral spine fusion.
This Level 1 quality trial will be the first such U.S. clinical study of MagnetOs for spinal fusion....
Astura Medical was granted FDA 510(k) clearance to market the Dolomite Stand-Alone Anterior Cervical Stabilization System.
Dolomite is the company's third technology providing a combined interbody and fixation option to receive 510k approval within the last 6 months....
CEO Nick Deeter says that 95% of children continue to receive adult orthopedic products that were never intended for them nor cleared by FDA for use in children. WishBone seeks to change the paradigm of pediatric orthopedics with its child-focused implants and sterile packaged disposable kits.
Eeric Truumees, M.D., First Vice President of NASS' Board of Directors, is optimistic that the online virtual annual meeting event in October will allow attendees to benefit from broader input in smaller doses.
Precision Spine commenced U.S. launch of the Slimplicity® HP Anterior Cervical Plating (ACP) System, which accommodates diverse patient anatomies and pathologies with low profile constrained, semi-constrained or hybrid constructs....
NuVasive voluntarily issued an Urgent Field Safety Notice in the U.K. and Ireland to address concerns identified by The Medicines and Healthcare Products Regulatory Agency over continued use of the MAGEC device for the treatment of scoliosis.
INSPAN announced successful results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan® ScrewLES™ Fusion interspinous fixation device.
Studies indicate that Tenon Medical's Catamaran™ Sacroiliac Joint Fixation System demonstrated an over 85% reduction in SIJ pain at six weeks, with radiographic evidence of solid continuous bridging bone across the treated joint at six months.
Studies show that RTI Surgical's TETRAfuse® PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time and a significantly higher push-out strength vs. standard PEEK.
CIGNA announced a positive coverage policy for minimally invasive sacroiliac joint fusion exclusive for FDA-cleared implants that are placed across the SI joint, such as SI-BONE's iFuse Implant System.