Product Description
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 made of high-strength Ti6Al4V Titanium Alloy, and the suture is constructed from Ultra High Molecular Weight Polyethylene (UHMWPE) for maximum durability.
Is the product provided sterile?
Yes, the system is EO (Ethylene Oxide) sterilized and individually packed in sterile blister boxes for immediate surgical use.
What certifications does the product hold?
The Suture Anchor System is fully certified with CE and ISO13485 standards, ensuring compliance with international medical device quality requirements.
What is the primary application for this anchor?
It is specifically designed for orthopedic surgeries, particularly sports medicine and joint arthroscopy, to connect soft tissue to bone.
Does the system include the inserter?
Yes, the system consists of the titanium anchor, the nonabsorbable suture, and the specialized inserter handle for precise placement.
What is the shelf life and warranty?
The product comes with a 3-year warranty and is designed for long-term stability as an orthopedic implant.
Tonk Orthopedic Implants
