📦 Basic Information
Certification
CE, ISO13485
Function
Connect The Soft Tissue and Bone
🔬 Product Description
The Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is manufactured from Ti6Al4V alloy, adhering to ISO5832-3:2016 standards. The suture is crafted from ultra-high molecular weight polyethylene (UHMWPE) yarn without coating, meeting ASTM F2848-17 requirements.
The blue suture features white UHMWPE dyed with FDA-approved blue material (code 73.1015). The stainless steel inserter components contacting the human body conform to ASTM F899-12b, while the handle is constructed from medical-grade polycarbonate and ABS material.
📋 Technical Specifications
| Item |
Details |
| Properties |
Implant Materials & Artificial Organs |
| Model Number |
WZ-MDT-S-01 |
| Instrument Classification |
Class II |
| Material |
Titanium Alloy |
| Specification |
Diameter 1.8 x 6mm |
| Package |
Sterile Packaging 1pc/package |
| Application |
Orthopedic Surgery / Implantology |
❓ Frequently Asked Questions
What is the primary material used for the suture anchors?
The anchors are made of high-strength Ti6Al4V Titanium alloy, which meets the ISO5832-3:2016 standards for surgical implants.
Is the suture material absorbable?
No, the system uses nonabsorbable sutures made of ultra-high molecular weight polyethylene (UHMWPE) yarn for long-term stability.
How is the product sterilized?
The suture anchor system is EO (Ethylene Oxide) sterilized and comes in individual sterile blister packaging.
What are the main clinical applications?
It is primarily used in orthopedic surgeries, specifically for shoulder arthroscopy and other procedures requiring the connection of soft tissue to bone.
What is the warranty period for this system?
The product comes with a 3-year warranty, ensuring reliability and performance for orthopedic applications.
Are samples available for evaluation?
Yes, samples can be provided upon request for professional medical evaluation and testing.
Nipa Orthopedic Implants
