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When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for deqenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 -- S1 vertebral joint, having fusions with autogenous bone graft. with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

The Moss Miami Spinal System Polyaxial Screws and Polyaxial Reduction Screws are designed to accept a 5.5mm rod and are available in various sizes.

The Moss Miami Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for the Moss Miami Spinal System Polyaxial Screws, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance tables, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment.

Instead, the submission relies on the established safety and effectiveness of predicate devices. The FDA determines "substantial equivalence" based on factors like:

• Intended Use: The Moss Miami Spinal System Polyaxial Screws share similar intended uses with the predicate devices.
• Technological Characteristics: The device is described as Polyaxial Screws designed to accept a 5.5mm rod, which is compared to existing Moss Miami Spinal System components.
• Performance Data: While not explicitly detailed, 510(k) submissions typically include non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate that the new device performs as safely and effectively as the predicate device and meets established engineering standards. However, these specific test results are not part of this summary document.

In summary, this document is a regulatory approval notice based on substantial equivalence, not a study report demonstrating acceptance criteria and device performance as would be found in a clinical trial.

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