(56 days)
Synthes Anterior Cervical Compression System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthrosis, and deformity (defined as kyphosis, lordosis or scoliosis).
The Synthes Anterior Cervical Compression System consists of plates with cortical and cancellous screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants of these systems are manufactured from Titanium Alloy (Ti-6A1-7Nb) and Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo).
Based on the provided text, the device in question is the "Synthes Anterior Cervical Compression System (ACCS)," which is a medical implant for spinal fixation. The provided text does not contain information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.
The documents are a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. These documents typically assert that the new device is as safe and effective as a legally marketed predicate device, often based on similar design, materials, and intended use, and sometimes supported by bench testing to ensure mechanical properties are comparable.
Therefore, I cannot provide the requested information. The text available only describes the device, its intended use, a predicate device, and the FDA's determination of substantial equivalence.
§ 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.