(80 days)
The MOSS Miami Spinal System, with either the existing smooth rods or the subject ratcher rods, is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, nonpedicle screw fixation the MOSS Miam Spinal System is intended to treat scobosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the LS-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 fration are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOSS MIAMI Spinal System is available in either Stainless Steel or Titanium. The following components are currently available in Stainless Steel: 5mm diameter longitudinal rods, 5-7mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5mm diameter longitudinal rods, 5-8mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers.
This submission describes the addition of 5mm x 12cm, 5mm x 48cm longitudinal ratchet rods to the Stainless Steel MOSS Miami Spinal System. The ratcher rods are similar to the MOSS Miami 5.0mm smooth longitudinal rods that have been previously cleared for anterior, posterior non-pedicle use and posterior pedicle fixation (Grades III or IV spondylolisthesis at LS-S1). The ratchet rods are manufactured from the same material and have the same lengths as the previously cleared, smooth, longitudinal rods. The only difference in design between the subject ratchet rods and the previously cleared, smooth, longitudinal rods is that the ratchet rods are cold-worked, creating a ringed outer suface.
The ratcher rod system was designed to make interoperative adjustments easier and quicker than with the smooth rod system When the ratchet rods are used, hooks and screws can be initially positioned on the rod and held in place with a loose connection, then ratcheted into final position and tightened. With the smooth rods, components are tightened onto then must be repeatedly loosened, moved and re-tightened until final positioning is accomplished.
The 5mm ratchet rods described in this submission are intended to be used with the existing MOSS Miami Stainless Steel hooks, screws, inner screw and outer locking nut which have previously been cleared for marketing.
The provided text is a 510(k) summary for a medical device (DePuy Motech MOSS Miami Spinal System) and does not describe acceptance criteria, performance studies, or ground truth establishment in the context of an AI/ML device. It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and mechanical properties. Therefore, I cannot extract the requested information.
§ 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.