Medical device firm Precision Spine has secured 510(k) clearance for its ShurFit ACIF 2C anterior cervical interbody system.
ShurFit ACIF 2C has been developed for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level.
It includes implants with various heights to accommodate individual patient anatomy and graft material size.
Designed to be implanted from the anterior approach at the C3 to C-7 disc levels, the system will be packed with autogenous bone graft to facilitate fusion and offer mechanical support to the implanted level until biologic fusion is achieved
The system is made by using medical grade polyetheretherketone (Peek Optima, LT1) and coated with pure Titanium (Ti) and Hydroxyapatite (HA).
The trapezoidal design of the system enables proper anterior placement, while an aggressive tooth patter helps resist implant expulsion.
The coating combination helps to enhance bony growth, and the implant’s large graft and contact areas offer plenty of biological coverage and optimizes vertebral body support while reducing the risk of subsidence.
Precision Spine COO Chris DeNicola said: “The ShurFit ACIF 2C System is an important addition to our growing portfolio of devices.
“and is further evidence of Precision Spine’s continuing commitment to work with surgeons in the design and commercialization of advanced products that utilize the latest technological advancements to help bring greater versatility, efficiency and cost-effectiveness to the OR.”