Providence Medical Technology has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its DTRAX spinal system.
The approval was granted for the system to be specifically used for posterior cervical fusion in patients with cervical degenerative disc disease.
Providence said the clearance offers a more specific indication for the DTRAX spinal system, which was a class I medical device indicated for access and preparation of a spinal joint to assist in fusion.
DTRAX spinal system is a set of surgical instruments, which includes various specialized single-use tools such as facet joint access instrument, lateral mass decortication trephine, mallet, cannula, decortication rasp, decortication burr, and bone graft tamp.
The instruments will enable surgeons to access the posterior cervical spine to carry out perform posterior cervical fusion by decorticating the bony surfaces of the posterior lateral mass and articular surfaces of the facet joints.
Later, the instruments will enable the application of autograft or allograft bone.
The diameter of the largest instrument is less than 1cm, which enables the surgeon to use a variety of surgical techniques such as tissue-sparing technique that decreases the dissection and stripping of muscles.
Providence Medical Technology CEO Jeff Smith said: “With the FDA 510(k) clearance of DTRAX Spinal System, Providence now has 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.”
Providence Medical Technology is engaged in the manufacturing of advanced instruments and implants for cervical fusion surgery.
The company also produces CAVUX intervertebral implants and ALLY bone and facet screws, in addition to DTRAX spinal instrumentation system.
In addition, the firm’s products are sterile-packaged and single-use, enabling to deliver consistent quality and performance.