Suture Anchor System consists of anchor, nonabsorbable suture and inserter. Anchor is made of Ti6Al4V alloy, which meets the requirement of ISO5832-3:2016. Suture is made of ultra high molecular weight polyethylene material without coating, it is woven from several UHMWPE yarn, which meets the requirement of ASTM F2848-17. Blue suture is from white ultra high molecular weight polyethylene, dyed with blue color material, code of blue material is 73.1015, which listed and approved by FDA. Part of inserter contacting human body is made of stainless steel conforming ASTM F899-12b. Handle of inserter will not contact human body, and it is made of polycarbonate and ABS material.
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Frequently Asked Questions
What materials are used in the Suture Anchor?
The anchor is constructed from high-quality Ti6Al4V Titanium alloy, which adheres to ISO5832-3:2016 standards for surgical implants.
Is the suture material safe and certified?
Yes, the suture is made from nonabsorbable ultra-high molecular weight polyethylene (UHMWPE) that meets ASTM F2848-17 requirements. The blue dye used is FDA-approved.
How is the product packaged for surgery?
Each Suture Anchor System is provided in sterile packaging (EO Sterile), with 1 piece per package, ensuring it is ready for immediate orthopedic use.
What are the primary clinical applications for this device?
It is specifically designed for orthopedic surgeries, such as shoulder arthroscopy, to securely connect soft tissue to bone.
Does the system include the inserter?
Yes, the system is a complete unit consisting of the anchor, the suture, and a stainless steel inserter for precise placement.
What certifications does the product hold?
The system is fully certified with CE and ISO13485 markings, complying with Class II instrument classifications.