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 (UHMWPE) 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 73.1015), which is approved by FDA. The part of the inserter contacting the human body is made of stainless steel conforming to ASTM F899-12b.
Frequently Asked Questions
What materials are used in the Suture Anchor System?
The anchor is constructed from high-grade Titanium Alloy (Ti6Al4V) complying with ISO5832-3 standards, and the suture is made of Ultra High Molecular Weight Polyethylene (UHMWPE).
Is the product provided in a sterile condition?
Yes, all units are EO (Ethylene Oxide) sterilized and individually sealed in sterile blister packaging for immediate surgical use.
What certifications does this system hold?
The Suture Anchor System is CE certified and manufactured under ISO13485 quality management systems, ensuring international medical standards.
Can this product be used for OEM requirements?
Yes, OEM services are available to meet specific clinical or branding requirements.
What is the typical application for this implant?
It is primarily used in orthopedic surgery and sports medicine to connect soft tissue (like tendons or ligaments) securely to the bone.
What is the warranty period for this medical device?
The product comes with a 3-year warranty, ensuring reliability and long-term performance in surgical applications.
WEX Medical
