SPINAL elements

SPARATAN S3 FACET SCREW System Implants and Instrumentation Instructions

6 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  SPARTAN® S3 FACET SCREW SYSTEM IMPLANTS AND INSTRUMENTATION This package insert covers the Spartan® S3 Facet Screw System and Manual Surgical Instruments that are used for the implantation of this system. GENRAL INFORMATION The Spartan® S3 Facet Screw System is designed to stabilize the facet joint for use in conjunction with a legally marketed interbody product. The screws are manufactured from titanium alloy (Ti-6Al-4V ELI) (per ASTM F136). They are offered in 4.3 and 5.0mm diameters and lengths of 20 to 55mm in increments of 5mm (40 to 55mm lengths not available in 4.3mm diameter) in cannulated lag and fully threaded screw varieties. INDICATIONS The Spartan® S3 Facet Screw System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: • Trauma, including spinal fractures and/or dislocations; • Spondylolisthesis; • Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; • Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability. The Spartan® S3 Facet Screw System will provide temporary stabilization as an adjunct to spinal fusion. CONTRAINDICATIONS 1. A case that requires removal of significant portions of the facets or lamina. 2. Active infection or risk of infection due to immunocompromise. 3. Local inflammation. 4. Fever or leukocytosis. 5. Spondylolysis – pars fracture. 6. Morbid obesity. 7. Pregnancy. 8. Mental illness. 9. Significantly distorted anatomy. 10. Presence of tumors. 11. Elevation in White Blood Cell differential count. 12. Elevation in sedimentation rate. 13. Osteoporosis/osteopenia. Osteoporosis is a relative contraindication that may limit the effectiveness of the fixation. 14. Metal allergy or intolerance. 15. Compromised bone integrity in or around the facets or pedicles. WARNING Implants provided sterile are sterilized through gamma irradiation. Do not re-sterilize implants provided sterile. Devices provided non-sterile must be cleaned and sterilized before use. Implants may be reprocessed prior to use and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. Implants that have come in direct contact with a patient or bio-contaminants should be disposed of.  LB-004  Page 1 of 6  Rev. 20201201
File Type: PDF
File Size: 104 KB
File Name: SPINAL elements - LB-004 - SPARATAN S3 FACET SCREW System Implants and Instrumentation Instructions - 2020-12 - 20201201.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions