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The MOSS Miami Spinal System is intended for non-cervical use in the spine.

When used with ante ior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to turnor, 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 with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the US-S1 vertebral joint, having fusions with antogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation 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 System is available in cither Stainless Steel or Titanium. The screws, polygial corect are available in Stainless Steel or Titanum. The screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial conrectors, staple washers and sacral extenders. The following screws, books, transwice organium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The resign, intended use, and material of these components have been cleared in previous 51 3(k) submissions.

The line extension covered in this submission are additional screw components to the existing 5mm Stainless Steel and 5.5mm Titanium alloy versions of the MOSS Miami Spinal System. The additional screws consist of Stainless Steel and Titanium 5-7mm diameter polyaxial and monoaxial screws in 5mm increments to provide screws lengths from 25mm to 90mm The additional screws also consist of Titanium 8mm diameter monoaxial screws in imm increments to provide screws lengths from 25mm to 90mm, and the addition of Stainless Steel 8mm monoaxial and polyaxial and of Titanium 8mm polyaxial screws in 1-1 lengths from 25mm to 90mm in 5mm increments. Additionally, the intended uses of the 7mm monoaxial and polyaxial screws, which were previously cleared as part of the 5mm stainless steel version of this system, were expanded to include anterior use.

The provided text does not contain information about acceptance criteria, device performance, or a study specifically designed for the DePuy Motech MOSS Miami Spinal System. The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details.

Here's why and what information is available:

• Nature of the Document: This is a regulatory submission for premarket notification (510(k)), not a clinical trial report or a detailed engineering performance study. The 510(k) process in the US allows a manufacturer to market a device by demonstrating that it is "substantially equivalent" to a legally marketed predicate device, without requiring extensive new clinical studies if the equivalence is clear.
• Focus on Substantial Equivalence: The document explicitly states, "Based on the information provided, DePuy believes that the subject additional screws in the MOSS Miami Spinal Systems and the additional indication of non-cervical anterior use of the Stainless Striel 7mm monoaxial and polyaxial screws are substantially equivalent to other currently legally marketed spinal systems' screws."
• Device Description: The "DEVICE DESCRIPTION AND INTENDED USE" sections detail the components, materials (Stainless Steel or Titanium), available sizes (diameters 5-8mm, lengths 25-90mm), and indications for use.
• Predicate Devices: The document lists several "SUBSTANTIALLY EQUIVALENT DEVICES" (e.g., DePuy Motech MOSS Miami Spinal Systems K933881, K950697, etc., and AcroMed VSP & ISOLA). The equivalence is largely based on similar design, intended use, and materials to these cleared devices, as well as the addition of different screw lengths and diameter.
• FDA Response: The FDA letter confirms the substantial equivalence with specific limitations and warnings regarding pedicle screw use, particularly for severe spondylolisthesis at L5-S1 and the requirement for device removal after fusion. This indicates that while the device was cleared, the FDA imposed strict conditions based on the existing evidence and regulatory framework for pedicle screws at the time.

In summary, the document serves to establish regulatory clearance by demonstrating equivalence, not to present novel performance data against specific acceptance criteria for a new device.

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