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.
Frequently Asked Questions
What materials are used in the Suture Anchor System?
The anchor is constructed from high-grade Ti6Al4V titanium alloy, while the nonabsorbable suture is made from ultra-high molecular weight polyethylene (UHMWPE) yarn, ensuring biocompatibility and strength.
Is the product provided sterile?
Yes, each suture anchor is provided in a sterile blister box packaging, processed using EO (Ethylene Oxide) sterilization for immediate surgical use.
What are the primary applications for this system?
It is primarily designed for orthopedic surgeries, specifically for shoulder arthroscopy and other procedures requiring the connection of soft tissue to bone.
What certifications does the product hold?
The Suture Anchor System is fully certified with CE and ISO13485 standards, meeting international requirements for medical implants.
What is the shelf life or warranty period?
The product comes with a 3-year warranty, reflecting its high-quality construction and material stability.
Can I request samples for evaluation?
Yes, samples can be provided for clinical evaluation and quality inspection upon request.