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The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following: 1. Spondylolisthesis. 2. Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies. 3. Degeneration of the facets with instability. The Facet-Link Facet Screw System is indicated for treatment of any or all of the following: 1. Pseudoarthrosis and failed previous fusion; 2. Spondylolisthesis; and 3. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

The Facet-Link Stabilization Platform consists of a series of devices designed to stabilize the spine. The Platform includes the MINI and HEMI devices. The devices are secured to the bone using Facet-Link trans-articular (facet) screws. The MINI device utilizes an adjustable monorail to crossconnect the Facet Screws, while the HEMI device uses a small, fixed plate as a cross-connector. The implants are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes. The devices are provided non-sterile and for single patient use. The Facet-Link Stabilization Platform requires several purpose manual orthopedic instruments for implantation, including a variety of k-wires, gauges, inserters, drills, and drivers.

The Facet-Link Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The methods of fixation are: Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle. The Facet-Link Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 (inclusive). The Facet-Link Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoarthrosis and failed previous fusion; (b) spondylolisthesis: and (c) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies. The Facet-Link Facet Screw System is intended for conventional surgical placement.

The Facet-Link Facet Screw System consists of a conical and threaded head, partially threaded lag screws and fully threaded screws designed to compact or fixate juxtaposed facet articular processes to enhance spinal fusion and stability. The screws and washers are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes. The Facet-Link Facet Screw System requires accessory general instruments for implantation. Instruments required for implantation may include a variety of k-wires, cannulae, drills, taps, and drivers.