Xtant Medical Receives Clearance of Expanded Indication for Ilium Fixation and Deformity

Xtant Medical Holdings, Inc. XTNT, a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, X-spine Systems, Inc. received FDA clearance of expanded indications to include ilium fixation as well as extended length screws for the Fortex® and the Xpress™ 2 Pedicle Screw System. The extended length screws are compatible with X-spine's current Fortex and Xpress instrument systems, offering a comprehensive pedicle screw portfolio. These dual lead, non-cannulated screws are indicated for use in posterior, non-cervical, T1-S2/Ilium pedicle spinal fixation. They are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumors, and failed previous fusion. "Elevated biomechanical forces make long segment lumbosacral spine fixation challenging to perform," states Dr. David Kirschman, Chief Scientific Officer of Xtant Medical and President of X-spine Systems. "Expanded indications into the ilium with extended implants will enhance fixation and enable surgeons to treat a wider variety of pathologies than sacral fixation alone."