The system is designed for use in skeletally mature patients with degenerative disc disease of the cervical spine at one or two disc levels
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Medical device firm Precision Spine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Dakota ACDF standalone system to treat degenerative disc disease (DDD).
The Dakota ACDF system includes a titanium plate polyetheretherketone (PEEK) cage with cortical cancellous screws to provide improved support and a cavity for autogenous bone graft to enable fusion.
The Dakota ACDF system is designated for use in skeletally mature patients with DDD of the cervical spine (C2-T1) at one or two disc levels.
Precision Spine stated that the DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.
Dakota system placed through anterior approach
An anterior approach will be used to place the Dakota ACDF standalone system at the C2 to T1 disc levels.
According to the company, patients getting a treatment with an intervertebral fusion device such as the Dakota ACDF system should have at least six weeks of non-operative treatment history prior to it.
Precision Spine chief operation officer Chris DeNicola said: “The Dakota ACDF System represents another example of how Precision Spine is making good on its commitment to develop surgeon-designed devices that embody the advanced features surgeons need to help improve OR efficiency and achieve positive patient outcomes.”
In March 2020, Precision Spine introduced the SureLOK MIS 3L percutaneous screw system in the US.
The SureLOK MIS 3L percutaneous screw system is designed to help spine surgeons to gain flexibility in their procedural approaches and application of its various components.
Based in Parsippany of New Jersey, Precision Spine provides spine products for the treatment of serious orthopaedic medical conditions. The company has manufacturing facilities in Pearl, Mississippi.