(29 days)
The Varifix System with pedicle screw attachment is only indicated for patients with severe spondylolisthesis, grades 3 and 4, of the fifth lumbar-first sacral (L5-S1) joint. This indication is for those who are receiving fusions using autogenous bone graft only. The Varifix System is to be removed after the development of a solid fusion mass.
The Varifix System with sacral screws and sublaminar wiring and the Varigrip System are intended for treatment of cases of degenerative disc diseases (ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiocraphic studies), soondylolisthesis, fracture, spinal stenosis, deformities (including scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and multi-operated back or revision of previous surgery. Other indications include degenerative lumbar scoliosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.
For indication other than severe spondylolisthesis (grade 3 or 4) at the L5-S1 vertebral joint this device in intended for sacral/iliac/lamina attachment only. The attachment points of the sacral screws are intended for the S1 or S2 locations. The sublaminar wire fixation levels range from L1 to L5. To facilitate fusion of the fifth lumbar-first sacral (L5-S1) the attachment points of the pedicle screws are limited to L3, L4, and L5 vertebrae. In addition, the titanium components are also intended for those individuals who have sensitivity to some of the elements present in stainless steel alloys. The Varigrip is intended to be attached to the non-cervical spine.
Modification to K954770 - Varigrip device components numbered CGT-SL and CGT-SL-15
This document is a 510(k) premarket notification from the FDA, specifically concerning a modification to the Varigrip device components. It does not contain information about acceptance criteria or a study proving device performance as typically expected for AI/ML medical devices.
Instead, this document is an approval letter based on "substantial equivalence" to a predicate device already on the market. This type of regulatory submission historically does not require the extensive performance testing and reporting that would lead to the information requested in your prompt.
Therefore, I cannot provide the requested table and details because they are not present in the provided text. The document's purpose is to grant market clearance, not to detail performance studies against predefined acceptance criteria for a novel device or software.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.