Precision Spine receives US FDA 510(k) clearance for ShurFit system

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Precision Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ShurFit ACIF 2C anterior cervical interbody system. The device is made from PEEK and coated with both titanium and hydroxyapatite.

According to a company release, the combination of the two biomaterials is expected to aid in the achievement of biologic fusion.

“The ShurFit ACIF 2C anterior cervical interbody system’s distinguishing feature is its unique coating of both titanium and hydroxyapatite, materials which have a long clinical history of facilitating bone on-growth, and makes enhanced fixation possible while the process of biologic fusion takes place,” said John Steck, clinical associate professor of Neurosurgery at the Louisiana State University Health Sciences Center, New Orleans, USA, who contributed to the design and development process with Precision Spine engineers.

The release states that this coating combination will encourage bony growth, while the implant’s large graft and contact areas will provide generous biological coverage and optimise vertebral body support, while also minimising the risk of subsidence. The trapezoidal design is intended to allow for proper anterior placement and an aggressive tooth patter helps resist implant expulsion. Strategically placed tantalum markers aim to facilitate radiographic implant positioning.

The system is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine at one disc level. It consists of implants with various heights to accommodate individual patient anatomy and graft material size. The system is implanted from the anterior approach at the C3 to C7 disc levels and is designed to be packed with autogenous bone graft.