The Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is constructed from Ti6Al4V alloy, conforming to ISO 5832-3:2016 standards. The suture is made from ultra-high molecular weight polyethylene (UHMWPE) material without coating, woven from multiple UHMWPE yarns meeting ASTM F2848-17 requirements. The blue suture is derived from white UHMWPE dyed with FDA-approved blue material (code 73.1015). The inserter components contacting the human body are made of stainless steel (ASTM F899-12b), while the handle is crafted from high-quality polycarbonate and ABS material.
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Frequently Asked Questions
What materials are used for the suture anchor?
The anchor is made of medical-grade Ti6Al4V alloy, which complies with ISO 5832-3 standards for biocompatibility and strength.
Is the suture material absorbable?
No, the suture is nonabsorbable. It is made of ultra-high molecular weight polyethylene (UHMWPE) for superior tensile strength.
How is the product sterilized for surgical use?
The suture anchor system is EO (Ethylene Oxide) sterilized to ensure it is safe for orthopedic surgery.
What certifications does this system hold?
The product is manufactured under strict quality controls and holds both CE and ISO certifications.
Can I request samples before placing a bulk order?
Yes, samples are provided for evaluation to ensure the product meets your surgical requirements.
What is the warranty period for this medical device?
We provide a 3-year warranty period for the Suture Anchor System starting from the date of delivery.
XOVEC Orthopedic Implants
