US FDA approves Spineology Rampart devices with allograft bone


Spineology has obtained US Food and Drug Administration (FDA)-clearance for the use of allograft bone with its Rampart Interbody Fusion Devices.

“This approval and our recent partnership expansion with Musculoskeletal Transplant Foundation (MTF) provides us the ability to pair MTF allografts with the Rampart family of interbody devices,” says John Booth, chief executive officer of Spineology. “In addition to reducing patient morbidity and enhancing surgical efficiency we expect this approval will provide Spineology with an excellent platform for delivery of our new Incite cortical fibres.”

According to a company release, Incite cortical fibres are a unique and versatile bone grafting solution offering an osteoconductive and inductive matrix, good handling properties, in-situ expansion and placement options via a variety of delivery methods.

The Rampart interbody fusion devices incorporate large graft windows, designed to facilitate healing, and a recently enhanced instrumentation system. Additionally, devices are now available sterile packed, eliminating the need for continual reprocessing, which reduces costs for our customers.

Spineology has also announced the completion of the Elite expandable interbody fusion system limited release. The implant is inserted into the disc space in a contracted minimal height, intended to minimise dissection and neural retraction. It is then incrementally expanded to restore the anatomical height of the space in order to maximise fit and potentially provide indirect neural decompression.

“During the Elite limited release, we took close note of surgeon feedback and what they desired to best treat their patients,” says Booth.

Mark Grubb of Cleveland, USA says, “The ability to deliver an Implant into the disc space at a minimal height in order to limit retraction and reliably control expansion is key in treating patients with spinal disorders. Elite’s instrumentation allows controlled implant delivery and precise height expansion, resulting in an overall effective system.”

Harel Deutsch of Chicago, USA says, “The broad selection of implant heights and lordotic options provide exceptional flexibility and the ability to treat a large range of patients. Additionally, the distraction capabilities and ability to lock the implant at any height during expansion is a feature that further enhances device fit and restoration potential.”