Elaris® Pedicle Screw System
The Elaris® Pedicle Screw System has received 510(k) clearance in the USA.
The Elaris Pedicle Screw System utilizes a standard pedicle screw implantation procedure. The surgeon can intra-operatively decide to provide adjunctive fixation to individual screws by using the BoneWelding® process to ultrasconically melt and extrude the Elaris Pin polymer through the screw’s fenestrations.
The Elaris Pin polymer can be ultrasonically deposited through the Elaris Pedicle Screw in skeletally mature patients as an adjunct to fusion for the indications listed below.
Our product 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
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, or lordosis
tumor, pseudarthrosis
and/or failed previous fusion
Elaris Pedicle Screw System – Implantation Procedure
01
The surgeon implants the screw using a standard pedicle screw procedure.
02
If adjunctive fixation is required, the surgeon inserts the Elaris Pin through the screw cannulation and attaches the automated handpiece.
02
If adjunctive fixation is required, the surgeon inserts the Elaris Pin through the screw cannulation and attaches the automated handpiece.
03
Using the foot pedal, the surgeon applies ultrasound during a maximum of 8 seconds to melt the polymer while the automated handpiece pushes the polymer melt through the screw fenestrations.
04
Dorsal fixation is finalized according to the standard protocol. Screws with the Elaris Pin are marked by differently color locking screws.
04
Dorsal fixation is finalized according to the standard protocol, and screws provided with Elaris Pin are marked by using different color locking screws.
Further 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 compared to screws without additional fixation.
Testing also has demonstrated that the pedicle screws can be removed as needed after polymer enhancement.
The Elaris Pedicle Screw System is patented in the US: US6921264 and US8974506
510(k) Number: K183091
Press Releases
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SpineWelding AG erhält Zulassung