(28 days)
Properly used, the VANTAGE™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.
The VANTAGE™ Anterior Fixation System consists of a variety of shapes and sizes of plates, screws, nuts, spacers and staples, 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 purpose of this submission is to add bolts to the VANTAGE™ Anterior Fixation System.
This document describes a 510(k) premarket notification for the VANTAGE™ Anterior Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a new clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving those criteria are met. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: This document does not present any specific performance metrics or acceptance criteria for the VANTAGE™ system.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth type for a test set: These elements are characteristic of a performance study designed to evaluate a device against predefined metrics, which is not the purpose of this 510(k) submission.
- Sample size and ground truth establishment for a training set: These details relate to the development and validation of an algorithm or diagnostic tool, which is not applicable to a mechanical fixation system like the VANTAGE™ Anterior Fixation System.
Instead of a new performance study, the core of this 510(k) submission is the statement in Section VI: "Documentation was provided which demonstrated the VANTAGE™ Anterior Fixation System to be substantially equivalent to itself." This indicates that Medtronic Sofamor Danek is submitting a modification (addition of bolts) to an already legally marketed device, and is asserting that the modified device remains substantially equivalent to its original, approved version. The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed.
§ 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.