Providence Medical’s DTrax Spinal System
FDA has cleared a Providence Medical Technology 510(k) for its DTrax Spinal System, indicated for use in posterior cervical fusion in patients with cervical degenerative disc disease. The set of surgical instruments include several specialized single-use devices such as a facet joint access instrument, lateral mass decortication trephine, mallet, cannula, decortication rasp, decortication burr, and bone graft tamp. The instruments allow surgeons to perform posterior cervical fusion by decorticating the bony surfaces of the posterior lateral mass and articular surfaces of the facet joints, according to the company. The instruments then enable the application of autograft or allograft bone. The diameter of the largest instrument is less than 1cm, which allows the surgeon to use a variety of surgical techniques including a tissue-sparing technique that reduces the dissection and stripping of muscles, it says.