Stryker’s Spine division today announced that its Tritanium® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has been implanted by 311 surgeons in more than 1,770 procedures across the U.S. since its introduction in late October. The company has sold more than 3,188 Tritanium C implants to date.
The company reports that the Tritanium C Anterior Cervical Cage is the newest addition to Stryker’s expanding line of spinal implants constructed from its proprietary Tritanium Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study,2* and the Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.3
Bradley Paddock, president of Stryker’s Spine division said, “As more spine surgeons gain experience using Tritanium cages, they are becoming believers in Tritanium Technology, which is designed to mimic the porosity of cancellous bone.” He added, “We are thrilled by the positive feedback the Tritanium C Anterior Cervical Cage is receiving from our surgeon customers.”
“The Tritanium C Anterior Cervical Cage is another great product by Stryker that brings revolutionary technology to the operating room,” said Dr. Lance Smith, Orthopedic Surgeon at McBride Orthopedic Hospital, Oklahoma City. “With many product sizes and lordosis options, I feel like I can match the anatomy and needs of the patient with the implant. I look forward to using the Tritanium C Cage product in more spinal surgeries.”
“I was intrigued by Tritanium because of the idea of bone in-growth as opposed to the on-growth of competitive products,” said Dr. Scott Kutz, Texas Back Institute, Plano, Texas. “I found the large graft window and imaging characteristics of Tritanium to be favorable versus other metal implants I’ve used.”
Tritanium Technology allows for the creation of porous structures designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.4 This “precise randomization”4 of fully interconnected pores differs from other technologies featuring longitudinal channels and traverse windows that create a uniform lattice structure, as well as cages offering porosity that is only present on the surface. Tritanium Cages feature an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment.
The Tritanium C Anterior Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration in September 2017 and was introduced to surgeons during the North American Spine Society conference Oct. 25–28, 2017. Full commercial launch occurred on Dec. 10, 2017.
1. PROJ43909 Tritanium technology claim support memo
2. RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
3. RD0000050927: Tritanium material capillary evaluation
4. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491