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?
The anchor is constructed from Ti6Al4V titanium alloy, meeting ISO5832-3:2016 standards, while the inserter's contact parts are made of surgical-grade stainless steel.
Is the suture material safe and approved?
Yes, the suture is made of ultra-high molecular weight polyethylene (UHMWPE). The blue coloring used is FDA-approved (code 73.1015).
How is the product sterilized?
The Suture Anchor System is provided EO Sterile (Ethylene Oxide sterilization) and comes in individual sterile blister packaging.
What are the primary clinical applications?
It is primarily used in orthopedic surgery, specifically for connecting soft tissue to bone during shoulder arthroscopy and other implantology procedures.
What is the warranty and lifespan of the product?
The system comes with a 3-year warranty. It is a Class II medical instrument designed for permanent or long-term implantation.
Can I request a sample before bulk ordering?
Yes, samples can be provided for evaluation. Please contact the sales department for availability and shipping terms.