Suture Anchor System Components:
The Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is constructed from high-grade Ti6Al4V alloy (conforming to ISO5832-3:2016). The nonabsorbable suture is made of Ultra High Molecular Weight Polyethylene (UHMWPE) without coating, woven from several UHMWPE yarns (conforming to ASTM F2848-17). The blue suture is derived from white UHMWPE dyed with FDA-approved medical-grade blue material.
The inserter's patient-contacting components are made of high-quality stainless steel (ASTM F899-12b), while the non-contact handle features an ergonomic design made from polycarbonate and ABS material.
Professional Manufacturing Standards
Our surgical consumables are manufactured under strict international quality benchmarks. We utilize Class 100,000 clean workshops and Class 10,000 purification laboratories to ensure the highest levels of safety and quality for orthopedic consumables, including Meniscal Repair Systems, Shaver Blades, and Suture Anchors.
Frequently Asked Questions
1. What materials are used in the Suture Anchor System?
The system utilizes high-strength Ti6Al4V alloy for the anchors and ultra-high molecular weight polyethylene (UHMWPE) for the sutures, ensuring biocompatibility and durability during soft tissue fixation.
2. Are the products certified for international use?
Yes, all products are fully compliant with CE certification and ISO 13485 standards, making them suitable for medical institutions worldwide.
3. Do you provide OEM services for customized needs?
We offer flexible OEM services, including custom designs and specialized packaging solutions to meet specific brand or surgical requirements.
4. How are the suture anchors sterilized?
The anchors and sutures are EO (Ethylene Oxide) sterilized and packaged in blister boxes to maintain sterility until the point of use.
5. What is the typical lead time for an order?
Delivery times are generally based on the payment schedule and order volume. We maintain a production capacity of 50,000 sets per year to ensure timely supply.
6. Can I request samples for clinical evaluation?
Yes, samples can be provided for quality evaluation and testing purposes. Please contact our sales representatives to coordinate the delivery and technical support.
Tandir Orthopedic Implants
