Pinnacle Spine receives FDA approval for lateral spine fusion system

Pinnacle Spine Group LLC announced the FDA approval and market availability of the InFill System for direct lateral spine fusion procedures to treat various spinal pathologies, according to a company press release.

Consisting of the InFill Interbody Fusion Device and InFill Graft Delivery System, the InFill System allows precise placement of approved biologic material into an implanted device, which improves endplate engagement with the biologic as compared to when the biologic is placed in the fusion device prior to implantation.

“It has long been a concern that biologic material packed into a fusion device prior to being implanted would not make optimal contact with the surfaces of typical of vertebral endplates,” Russell W. Nelson, MD, chief medical advisor at Pinnacle, stated in the release. “Filling the device post implantation significantly improves the contact of the biologic with the adjacent endplates, with the expectation that the increased contact will promote more rapid bone healing.”

The InFill System includes an array of lateral interbody fusion devices supplied in a sterile, single-use package. The implant is designed to provide a generous bone grafting area with endplate contact surfaces that optimize the weight bearing properties of the cage, while the Graft Delivery System is designed to facilitate controlled precise placement of biologic material into the implanted device. The System includes comprehensive instrumentation, such as an innovative retractor system, extensive disc and endplate preparation options and other specialized instrumentation to address the more challenging fusion levels, according to the press release.