Stryker Corporation’s spine division launched the Xia 4.5 Cortical Trajectory implants and instruments at the American Academy of Orthopaedic Surgeon’s annual meeting in Orlando, Florida on March 2, 2016. Two days later the company announced FDA 510(k) clearance of its Tritanium PL Posterior Lumbar Cage.
The company says Xia 4.5 implants and instruments facilitate a less invasive posterior lumbar interbody procedure and helps achieve decompression and fixation in spine surgeon patients.
According to the company, the implant and instruments are used in less invasive, “LITe LIF posterior lumbar interbody fusion procedures for patients with degenerative disc disease, spondylolisthesis and trauma, among other indications. The cortical trajectory procedure facilitates a smaller midline incision to help achieve decompression, fixation and fusion. It also is intended to be more muscle sparing than standard open procedures that require lateral dissection, and its reduced incision may allow for more efficient exposure and closure time.”
The implants, says the company, “utilize the low profile tulip head of Stryker’s Xia 4.5 Spinal System to allow for maximum visualization, and can be used with the LITe Midline Retractor that allows for optimized visualization of the surgical site without the need for headlamps. The Xia CT implants and instruments offer both cannulated and non-cannulated options. The cannulated screw offering and cannulated tap markers allow for screw insertion over a guide wire. The Xia CT implants and instruments are compatible with existing Xia 4.5 implants and instrumentation.”
Tritanium PL Posterior Lumbar Cage
The March 4, 2016 announcement of the FDA clearance stated that the Tritanium Lumbar Cage is an intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease. Constructed from the company’s proprietary Tritanium technology, the cages are manufactured via a 3D additive process.
The company says the cages are offered in a variety of widths, lengths, heights, and lordotic angles, “designed to adapt to a variety of patient anatomies and are designed to be implanted via a posterior approach. The cage is intended for use in patients with degenerative disc disease, grade I spondylolisthesis, and degenerative scoliosis.”
The company also says the large lateral windows and open architecture of the cages, “allow visualization of fusion on CT and X-ray. Its solid-tipped, precisely angled serrations are designed for bidirectional fixation and to maximize surface area for endplate contact with the implant. The Tritanium PL Cage is also designed to address the potential for subsidence into the endplates.”
Brad Paddock, president of Stryker’s spine division, said it was “an exciting” time for Stryker. “Our advanced 3D additive manufacturing capabilities allow us to precisely manufacture the porous structures of Tritanium and specific implant geometries. We are pleased to bring this technology to our spine surgeon community and their patients.”
The cage is intended for use with autograft and/or allogenic bone graft, comprised of cancellous and/or corticocancellous bone graft inside the device, and with supplemental spinal fixation systems that have been cleared by the FDA for use in the lumbosacral spine (i.e., pedicle screws, rods, or plates). The implants will be available in the second quarter of 2016.
