Xtant Medical Titanium Cervical System Cleared

The FDA has 510(k) cleared Xtant Medical Holdings, Inc.’s InTice-C Porous Titanium Cervical Interbody System.

The system uses the company’s OsteoSync Ti titanium scaffold material. The company says the material more closely resembles the bioscaffold of cancellous bone and combines its hardware and biologic portfolios. InTice-C is also cleared for use with the company’s proprietary allograft lines, including OsteoSponge, 3Demin Cortical Fibers, and OsteoVive viable cell allograft.

Gregory Juda, M.D., the company’s chief scientific officer and general manager, said the implant is the company’s first spinal implant using their porous titanium material. “The porous architecture of the titanium was designed to improve implant fixation, both prior and post fusion. We expect a positive reception of this technology from our surgeon customers in the cervical spine market.”

The system is offered in multiple footprint, height and endplate options. The company states the pure titanium structure “optimizes vascularization to the fusion site allowing the implant to be a participant in the fusion process.” In addition, the company says the implant “utilizes machined endplate structures in conjunction with the inherent texture of the porous titanium to provide migration resistance. The implant is offered in individual sterile packages.”

The company began operations in 1998 as Bacterin, Inc., a spin out of the Center for Biofilm Engineering at Montana State University. In 2004, the company went public as Bacterin International, Inc. In July 2015, Bacterin acquired X-spine Systems, Inc. for approximately $60 million and changed its corporate name to Xtant Medical Holdings, Inc.

Today, the company develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets, “serving the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries.”