Globus Medical SILC Fixation System
- CataBlog
- Jan 15, 2018
- 2 min read
Vendor/Manufacturer: Globus Medical Inc.
Product/Product Line: SILC® Fixation System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3010
FDA Regulation Description Classification Name:
Bone Fixation Cerclage
FDA Classification Product Code: OWI
FDA Classification Product Code Device Name:
Bone Fixation Cerclage, Sublaminar
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The SILC® Fixation System consists of bands and cords, clamps to mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. The bands and cords are manufactured from polyethylene terephthalate (PET). The bands have commercially pure titanium tips, as specified in ASTM F67, which are detached after insertion and are not intended to be implanted. The clamps are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F138, F1295, F1472, and F1537. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants.
Indications for Use:
The SILC® Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.
The SILC® Fixation System may also be used in conjunction with other medical implants made of similar metals whenever “wiring” may help secure the attachment of other implants.
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