🛠️ Product Description
Suture Anchor System consists of anchor, nonabsorbable suture and inserter. The 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, woven from several UHMWPE yarns, meeting ASTM F2848-17 standards. The blue suture is dyed with FDA-approved blue material (code 73.1015). The inserter tip is crafted from stainless steel conforming to ASTM F899-12b, while the handle is constructed from polycarbonate and ABS material.
❓ Frequently Asked Questions
What materials are used in the Suture Anchor System?
The anchor is made of high-grade Ti6Al4V Titanium alloy (ISO5832-3), and the suture is constructed from Ultra High Molecular Weight Polyethylene (UHMWPE) for maximum strength and biocompatibility.
How is the product sterilized?
All suture anchors are provided EO (Ethylene Oxide) Sterile and come in individual sterile blister packaging to ensure safety for surgical use.
Does the product have international certifications?
Yes, the system is Class II medical device certified with CE and ISO markings, meeting global standards for orthopedic implants.
What is the primary surgical application?
It is specifically designed for orthopedic sports medicine surgeries to securely connect soft tissues, such as ligaments or tendons, to the bone.
What is the warranty and shelf life?
The product comes with a 3-year warranty and is designed for long-term stability within the human body.
Are samples available for evaluation?
Yes, samples can be provided for clinical evaluation and quality inspection upon request.
Horaizon Orthopedic Implants
