The Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is manufactured from Ti6Al4V alloy, conforming to ISO 5832-3:2016 standards. The suture is crafted from ultra-high molecular weight polyethylene (UHMWPE) material, woven for superior strength without coating, meeting ASTM F2848-17 requirements. The blue suture variant utilizes FDA-approved coloring materials. The inserter features a stainless steel contact point (ASTM F899-12b) with a polycarbonate and ABS handle for ergonomic use.
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Frequently Asked Questions
What material is the anchor made of?
The anchor is constructed from high-grade Ti6Al4V alloy, which meets international ISO 5832-3:2016 standards for surgical implants.
What type of suture is used in this system?
The system utilizes nonabsorbable sutures made of Ultra High Molecular Weight Polyethylene (UHMWPE), providing exceptional strength and durability.
Is the product provided in a sterile condition?
Yes, all units are EO (Ethylene Oxide) sterilized and packaged in blister boxes to ensure safety for orthopedic surgery.
What certifications does the product hold?
The Suture Anchor System is fully certified with CE and ISO13485, ensuring it meets strict quality and safety regulations for medical devices.
What is the intended clinical use of this device?
It is specifically designed for orthopedic surgeries to securely connect soft tissue to bone.
What is the warranty period for this product?
We provide a 3-year warranty for the Suture Anchor System from the date of purchase.
Sete Orthopedic Implants
