Search Results

The MSD SiLo™ System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the MSD SiLo™ components are intended for the following indications: (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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The MSD SiLo™ Spinal System consists of a variety of rods, hooks, screws, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The MSD SiLo™ Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The MSD SiLo™ Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the MSD SiLo™ Spinal System. These components include CD HORIZON® rods and CROSSLINK® plates.

MSD SiLo™ hooks are intended for posterior use only.

This document does not contain information about acceptance criteria, device performance metrics, or any study design that would typically be used to prove a device meets acceptance criteria.

The document is a 510(k) premarket notification summary and an FDA clearance letter for the MSD SiLo™ Spinal System. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (CD HORIZON® Spinal System components cleared in K041030).

Here's what the document does provide and why it doesn't fit the requested criteria:

• Substantial Equivalence (Section VI): It explicitly states that "Documentation, including test reports, was provided which demonstrated the MSD SiLo™ Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041030." This means the device met the regulatory requirement for substantial equivalence to a predicate, not that it underwent a specific performance study against defined acceptance criteria (e.g., sensitivity, specificity for an AI algorithm).
• Device Description and Indications for Use: These sections describe what the device is and what it's intended to treat, but not its performance.

Therefore, I cannot populate the requested table or answer the study-related questions based on the provided text.

To answer your specific questions, information about a performance study (clinical or in-vitro) with defined acceptance criteria for the MSD SiLo™ Spinal System would be needed. This document indicates the device was cleared through the 510(k) pathway, which oftentimes relies on demonstrating equivalence rather than requiring extensive new clinical performance studies against specific endpoints, especially for mechanical devices like spinal systems.

Ask a specific question about this device