Search Results
Found 1 results
510(k) Data Aggregation
K Number
K183091Device Name
Elaris Pedicle Screw System
Manufacturer
Date Cleared
2019-08-02
(269 days)
Product Code
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
SpineWelding AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Elaris Pedicle Screw System is intended to provide immobilization 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 deqeneration 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. 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 above.
Device Description
The ELARIS Pedicle Screw System consists of the following components: Elaris Pedicle Screws, Elaris Pins, Elaris Rod, Elaris Set Screw, Dedicated Manual Instruments, and an Ultrasonic System, which includes the ultrasonic generator (BoneWelder 150-W1) with corresponding footswitch and power cord, and the spring loaded Elaris Handpiece with the Elaris Connector, which rigidly couples the housing of the Elaris Handpiece with the Elaris Pedicle Screw. The cannulated pedicle screws are available in two diameters and four lengths and contain a distal fenestration to optionally allow injection of resorbable polymer into the cancellous bone of the vertebral body. The Ti alloy screws are multiaxial, and are rigidly attached to the set screw. The Elaris Pin can intraoperatively be inserted into the screws cannulation. The Elaris handpiece can be connected to the pedicle screw head, and using the BoneWelder, the polymer is ultrasonically heated so that it melts and is extruded out of the fenestrations.
Ask a Question
Ask a specific question about this device
Page 1 of 1