Stryker receives FDA clearance for 3-D printed spinal fusion implant
Stryker ($SYK) announced FDA clearance of the 3-D printed Tritanium PL Posterior Lumbar Cage, marking another step in its strategy to deploy the new additive manufacturing technology to create new products and earn incremental revenue growth.
The device is made from novel, highly porous titanium material designed for bone ingrowth and fixation in spinal conditions like degenerative disc disease, grade I spondylolisthesis, and degenerative scoliosis, the company said in a release.
To be commercialized in Q2 2016, the lumbar cage is intended for use with autografts and/or allogenic bone grafts, as well as supplemental spinal fixation systems.
"We are committed to offering a full range of innovative spinal products that allow surgeons to help their patients return to a more active lifestyle," said Brad Paddock, the president of Stryker's spine division, in a statement. "Our advanced 3D additive manufacturing capabilities allow us to precisely manufacture the porous structures of Tritanium and specific implant geometries. We are pleased to bring this technology to our spine surgeon community and their patients."
Stryker said it was anticipating launch of a 3-D printed spinal implant during its most recent call, which focused on the topic extensively. Stryker apparently has a "huge lineup" of titanium, 3-D printed prototypes in the pipeline, on top of the two 3-D printed knee implants that it already sells. Also in the works is a new 3-D printing manufacturing facility.
|Smith & Nephew's Redapt Revision Acetabular Fully Porous Cup--Courtesy of Smith & Nephew|
Stryker CEO Kevin Lobo said during the earnings call that 3-D printed implants give its sales force "something that they can go talk to a competitive surgeon about. So, I would say it's not a huge contributor, but it's an extra shot in the arm."
Meanwhile, competitor Smith & Nephew ($SNN) touted the recent launch of its first 3-D printed hip implant at the ongoing meeting of the American Academy of Orthopaedic Surgeons in Orlando, FL.
And Zimmer Biomet ($ZBH) announced the launch of three hip implants at the conference: a femoral stem, an acetabular shell and associated implantation system, and a femoral revision system.
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