It took the FDA about six weeks to give Providence Medical Technology, Inc., clearance to expand indications for its DTRAX spinal system for use in posterior cervical fusion in patients with cervical degenerative disc disease.
Previously, the device was only broadly indicated for access and preparation of a spinal joint to aid in fusion.
Providence CEO Jeff Smith said on May 22, 2018, the 510(k) clearance gives the company “the only sterile-packaged, single-use set of instruments specifically cleared for posterior cervical fusion. Our unique, single-use instruments assist surgeons in performing the steps of a traditional posterior cervical fusion. We believe DTRAX represents a landmark innovation for cervical fusion benefiting patients, surgeons, facilities, and payers.”
“The system is a set of surgical instruments consisting of several specialized single-use instruments including a facet joint access instrument, lateral mass decortication trephine, mallet, cannula, decortication rasp, decortication burr, and bone graft tamp.”
The company says “These instruments allow surgeons to access the posterior cervical spine to perform posterior cervical fusion by decorticating the bony surfaces of the posterior lateral mass and articular surfaces of the facet joints. The instruments then enable the application of autograft or allograft bone.”
And because the diameter of the largest instrument is less than 1cm, surgeons can use a variety of surgical techniques including a tissue-sparing technique that reduces the dissection and stripping of muscles.
The privately held Pleasanton, California, company was co-founded by Smith in 2008.
