1st Cleared Porous Pedicle Screw System Is “Therapeutic Hardware”

In a move that blends cutting-edge biomechanics with next-generation additive manufacturing, the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Allumin8, Inc.’s A8 INTEGR8™ Porous Pedicle Screw System — a first-of-its-kind 3D-printed screw platform for thoracolumbar fusion.

The system is cleared for use with autograft or allograft to immobilize and stabilize spinal segments in skeletally mature patients undergoing fusion for a familiar lineup of indications: degenerative disc disease, spondylolisthesis, trauma, stenosis, deformity correction, tumor, pseudoarthrosis, and failed previous fusion.