Sports Medicine Surgery for Repair Restruction Rotator Cuff Tendon 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.
Specification
Item
Value
Properties
Implant Materials & Artificial Organs
Model Number
WZ-MDT-S-01
Instrument Classification
Class II
Product Name
Suture Anchor System
Material
Titanium Alloy
Color
Silver + Orange
Specification
Diameter 1.8x6mm
Certificate
CE
Package
Sterile Packaging 1pc/package
Application
Implantology / Orthopedic Surgery
Packaging & Shipping
Frequently Asked Questions
What materials are used for the suture anchor?
The anchor is made of high-quality Ti6Al4V alloy, which meets ISO5832-3:2016 standards for medical implants.
What is the suture material composed of?
The suture is made from ultra-high molecular weight polyethylene (UHMWPE) yarn, complying with ASTM F2848-17 requirements.
Is the Suture Anchor System provided sterile?
Yes, the system is EO sterile and provided in sterile blister box packaging, with 1 piece per package.
What surgical procedures is this product designed for?
It is primarily used in sports medicine and orthopedic surgeries, specifically for rotator cuff tendon repair and reconstruction.
What are the available dimensions for the anchor?
The standard specification for this model features a diameter of 1.8mm and a length of 6mm.
What is the shelf life and warranty for this product?
The product comes with a 3-year warranty and is classified as a Class II medical instrument.