US FDA clears Spineology Elite for narrower size and expanded indication

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Spineology Elite with Incite bone graft

The US Food and Drug Administration has cleared Spineology’s Elite expandable interbody fusion system for a new size and an expanded indication. Included in the clearance is the addition of a narrower, 10mm, version of the device and an indication to utilise the devices with allograft bone.

Mark Grubb—an orthopaedic surgeon from Cleveland, USA—says, “The minimal initial starting height and a 10mm wide footprint reduces neural retraction requirements. Additionally, having the Incite bone graft that expands with the implant helps ensure good graft apposition.”

The implant is inserted into the disc space at a contracted minimum height, and expanded once in position to restore anatomic disc height, provide anterior column support, and potentially facilitate indirect decompression. According to a press release, Elite offers the surgeon the ability to control device expansion and lock the device at any position in the expansion range. The Elite implant is constructed of titanium alloy and has a large graft window intended to enable bone through-growth.

Incite cortical Fibres are fibre-based bone allografts. According to the release, they are naturally osteoconductive and carefully processed to maintain their osteoinductive potential. These freeze-dried grafts are designed to expand when hydrated in-situ, eliminating concern of graft off-loading following implant expansion.