Stryker wins FDA nod for Tritanium TL fusion cage
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its 3D-printed Tritanium TL curved posterior lumbar cage designed for use in lumbar fixation procedures.
The newly cleared cage is a hollow implant consisting of solid and porous structures built using the company’s AMagine proprietary additive manufacturing techniques, the Kalamazoo, Mich.-based company said. The system consists of a central graft window and lateral windows to reduce stiffness and aid in visualization during procedures.
The device also features Stryker’s Tritanium porous titanium material designed for bone ingrowth and biological fixation, which the company claims may be able wick or retain fluid compared to traditional titanium material.
“The Tritanium TL cage is the latest addition to our highly successful Tritanium portfolio, which has been embraced by spinal surgeons nationwide. The TL cage is accompanied by a new anterior placement system that is designed for versatility and procedural flexibility. From instrumentation ergonomics and visualization, to a simplified technique with tactile feedback, Tritanium TL’s anterior placement system and cage design redefine implant steerability for surgeons,” Stryker spine division prez Bradley Paddock said in a press release.
Earlier this week, Stryker readied a $600 million debt offering it plans to use to retire other deb