The Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is constructed from Ti6Al4V alloy, meticulously designed to meet ISO5832-3:2016 requirements. The accompanying suture is crafted from ultra-high molecular weight polyethylene (UHMWPE) material, woven for maximum strength without additional coating, adhering to ASTM F2848-17 standards. For identification and safety, the blue suture utilizes FDA-approved coloring materials.
The inserter is engineered for precision and safety. Parts contacting the human body are made of medical-grade stainless steel (ASTM F899-12b), while the ergonomic handle is constructed from high-quality polycarbonate and ABS material to ensure steady control during orthopedic procedures.
Quality Assurance & Manufacturing
Manufacturing processes are conducted within Class 100,000 clean workshops and Class 10,000 purification laboratories. This ensures that every surgical consumable, from suture anchors to meniscal repair systems, meets the highest international quality benchmarks, including full CE certification and ISO 13485 standards.
Frequently Asked Questions
Q: What materials are used for the suture anchors?
A: The anchors are primarily made of Ti6Al4V Titanium alloy or PEEK material, both of which are high-strength and biocompatible for orthopedic surgery.
Q: Is the suture material absorbable or non-absorbable?
A: The system uses non-absorbable sutures made of ultra-high molecular weight polyethylene (UHMWPE), known for its exceptional tensile strength and durability.
Q: What certifications do these medical devices hold?
A: Our products are fully compliant with CE certification and ISO 13485 standards, ensuring they meet international medical quality and safety regulations.
Q: How is the product sterilized before delivery?
A: All suture anchor systems are EO (Ethylene Oxide) sterilized to ensure the highest level of safety for clinical use.
Q: Do you offer OEM or customization services?
A: Yes, we provide flexible OEM services, including custom designs and specialized packaging solutions to meet specific brand or clinical requirements.
Q: What is the standard warranty period for these instruments?
A: We offer a 3-year warranty on our suture anchor systems, reflecting our confidence in the product's durability and performance.
DTRX Orthopedic Implants
