(158 days)
The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis.
- Spondylolysis.
- Spondylolisthesis.
- Fracture.
- Neoplastic disease.
- Unsuccessful previous fusion surgery.
- Lordotic deformities of the spine.
- Idiopathic thoracolumbar or lumbar scoliosis
- Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
- Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.
The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.
The provided text is a 510(k) premarket notification for the ZPLATE-ATL™ Anterior Spinal Fixation System. It focuses on the substantial equivalence of the device to itself, indicating that it is a modification or re-filing of an already cleared device.
Therefore, this document does not contain information about acceptance criteria and a study proving a device meets those criteria, as it would for a novel device. The FDA's letter explicitly states: "Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself." This means the current submission is for an already cleared device, possibly with minor modifications that do not warrant new clinical studies or the establishment of new performance acceptance criteria.
To answer your request, if this were a submission for a new device, the information you're asking for would typically be found in sections detailing performance data, clinical studies, or non-clinical tests. This document instead states that the device is substantially equivalent to itself, which bypasses the need for the kind of studies you describe in your prompt.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
§ 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.