FDA clears Stryker’s Tritanium PL lumbar cage

Stryker (NYSE:SYK) said today that it won 510(k) clearance from the FDA for its Tritanium PL posterior lumbar cage for lumbar spinal fixation.

The Kalamazoo, Mich.-based orthopedics giant said it’s planning on a 2nd-quarter release for the device, made by its Stryker Spine division using a highly porous form of titanium designed to help bone ingrowth. Stryker also makes a hip implant with the Tritanium metal.

“This is an exciting time for Stryker,” spine president Brad Paddock said in prepared remarks. “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. 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 Tritanium PL cage is designed to be used with autograft and/or allogenic bone graft and pedicle screws, rods, or plates, Stryker said.

The company, which earlier this week re-upped its sponsorship of the PGA Tour, also this week announced the release of its Aero-C device for cervical fusion procedures at the annual meeting of the American Academy of Orthopaedic Surgeons in Orlando.

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