(59 days)
The X-Spine SCP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- Spondylolisthesis, .
- Trauma (i.e., fractures or dislocations), .
- Tumors, ●
- Deformity (defined as kyphosis, lordosis, or scoliosis)
- Pseudoarthrosis, and/or
- Failed previous fusions.
The X-Spine Spider Cervical Plating (SCP) System includes titanium alloy anterior cervical plates and bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The implant components are provided clean and non-sterile.
The provided 510(k) summary for the Spider Cervical Plating (SCP) System does not contain information regarding detailed acceptance criteria or a specific study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy.
The summary states:
"Performance Data: Performance data were submitted to characterize the X-Spine SCP System."
However, it does not elaborate on what this performance data entails, what specific acceptance criteria were used, or the results of any such study related to the device's functional or clinical performance.
Based on the provided text, the 510(k) emphasizes the substantial equivalence of the SCP System to a legally marketed predicate device (Synthes CSLP System). This regulatory pathway often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a predicate device, rather than requiring extensive new clinical performance studies.
Therefore, I cannot fulfill your request for the specific acceptance criteria and study details because they are not present in the provided document. The submission focuses on device description, intended use, and comparison to a predicate device for regulatory clearance.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.