The fixation of the Elaris Pedicle Screws in bone can be enhanced with resorbable polymer.  The solid polymer pins can be ultrasonically liquified and extruded through the screw’s fenestrations. In the bone, the polymer immediately solidifies and creates a strong bond of the screw with the surrounding bone, significantly increasing the stability of the screws in the vertebral body.

The new ELARIS® II Multiple Polymer Enhancement Technology allows the extrusion of up to three polymeric pins from the screw’s fenestrations (FDA clearance pending, not for sale in the USA).

The multiple polymer extrusion allows a significant enhancement of the pull-out and toggling resistance of the screw.

Elaris Technology – Advantages

• The surgeon can decide intraoperatively to enhance single screws directly after placement.
• The polymer enhancement process takes only a few seconds without cumbersome preparation.
• The enhanced fixation effect is immediate and on par with state-of-the-art enhancement technologies.
• There is no risk of uncontrolled flow of the polymer outside the vertebral body.
• The pedicle screws can be removed as needed after polymer extrusion with the help of the ultrasonic handpiece.

Elaris^® I Pedicle Screw System

The Elaris® I Pedicle Screw System with single polymer extrusion has already received 510(k) clearance in the USA.

Intended Use:

The Elaris® I Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments through posterior non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following indications:

• Degenerative disc disease
• Trauma, Tumor
• Spinal stenosis, Spondylolisthesis
• Scoliosis, kyphosis
• Pseudarthrosis, Failed previous fusion

Polymer Material Characteristics

In the Elaris Pedicle Screw System, the Elaris Pin polymer is made of a biocompatible and fully bioresorbable Poly-L-lactide-co-D,L-lactide (PLDLLA). Because the polymer is bioresorbable, it undergoes the natural physiologic process of hydrolysis, and is gradually metabolized into H₂O and CO₂.

Bench and animal testing have demonstrated that the polymer enhancement provides appropriate dynamic pullout strength for up to 52 weeks as well as improved resistance to toggle loosening.

The Elaris Pedicle Screw System is patented in the US: US6921264 and US8974506

510(k) Number: K183091

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