The Composite Absorbable Anchor System is a medical-grade biocomposite implant designed for soft tissue-to-bone fixation in arthroscopic and open orthopedic procedures.
Product Specifications
|
Anchor Type |
Diameter Range |
Length Range |
Suture Configuration |
Primary Application |
|
Solid Strike-In |
2.0mm, 2.4mm, 3.0mm |
12mm |
Blue & White #2 Suture |
Small joint repair, labral repair |
|
Hollow Strike-In |
3.0mm, 3.5mm, 4.5mm |
15.5mm, 19.5mm, 24mm |
Blue & White #2 Suture |
Shoulder cuff repair, glenoid labrum repair |
|
Split Spin-In |
3.5mm, 4.75mm, 5.5mm |
15.8mm, 19.1mm |
Blue & White 2# Suture |
Double-row rotator cuff repair, ACL reconstruction |
|
Full Hollow Screw-In |
4.5mm, 5.5mm |
19.5mm |
White-Blue-White 2# Suture (Double Strands) |
Meniscal root tear repair, tendon-bone fusion |
|
Conventional Spin-In |
4.5mm, 5.5mm |
17.5mm |
White-Blue-White 2# Suture (Double/Three Strands) |
Multijoint soft tissue fixation, revision surgeries |
Core Advantages
· Optimized thread design increases cancellous bone fixation strength
· Controlled porosity structure enables predictable degradation behavior
· Reinforced insertion tip supports smooth arthroscopic delivery
· Radiolucent material eliminates MRI/CT imaging artifacts
· Biocompatible composition reduces inflammatory response
Manufacturing & Quality System
The Composite Absorbable Anchor System is manufactured under a fully controlled medical device quality management system to ensure consistency, traceability, and regulatory compliance.
Our production capabilities include:
- ISO 13485 certified quality management system
- Controlled cleanroom manufacturing environment (Class 100,000 or equivalent)
- CNC precision machining and advanced polymer molding processes
- Full batch traceability system covering raw materials, production process, and sterilization records
Each production batch undergoes dimensional inspection, mechanical performance verification, and material consistency testing to ensure stable clinical performance.
Regulatory Compliance
The system is developed in accordance with internationally recognized medical device standards, including:
- ISO 13485 Quality Management System
- ISO 10993 Biocompatibility Evaluation for Implantable Devices
- Validated EO (Ethylene Oxide) or Gamma sterilization processes
- CE marking and FDA regulatory support (market-dependent requirements)
Comprehensive technical documentation packages are available.
Frequently Asked Questions (FAQ)
Q: How long does a composite absorbable anchor take to dissolve?
A: The degradation time depends on material composition and clinical application, typically aligned with tissue healing stages.
Q: Can composite absorbable anchors be used in arthroscopic surgery?
A: Yes, they are specifically designed for arthroscopic delivery systems and minimally invasive procedures.
Q: Do absorbable anchors require removal surgery?
A: No, they are designed to gradually absorb in the body and do not require secondary removal.
Q: Are composite anchors better than metal anchors?
A: Composite absorbable anchors eliminate imaging artifacts and support biological integration, while metallic anchors provide permanent fixation.
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