Stryker wins FDA 510(k) for 3D-printed Tritanium C anterior cervical cage

Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its Tritanium C 3D-printed anterior cervical cage interbody fusion cage desigend for cervical spinal use. The newly cleared Tritanium C cage is constructed with the company’s Tritanium in-growth technology featuring a highly porous titanium material designed for bone ingrowth and biological fixation. The company claims the porous structure of the material creates a favorable environment for cell attachment and proliferation, and has been verified by in-vitro studies. “We are excited to introduce the Tritanium C anterior cervical cage following the successful launch last year of our Tritanium posterior lumbar cage. The benefits of additive manufacturing to create highly porous spinal implants that are ‘engineered for bone’ are becoming increasingly clear. Additive manufacturing allows us to push beyond conventional manufacturing techniques to address design complexity and achieve previously unmanufacturable geometries, while delivering the performance, reproducibility, and quality our customers have come to expect,” Stryker spine division prez Bradley Paddock said in a press release. The Tritanium C cage features an open central graft window and lateral windows to reduce stiffness and minimize subsidence, Stryker said. Earlier this month, Stryker said it closed its previously announced $700 million acquisition of fluorescence imaging technology developer Novadaq Technologies (TSE:NVDQ). The ...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Stryker Source Type: news