Product Name: Suture Button Suspensory Fixation Device
Model/Type: Cortical Button with Suture Loops
Button Material: Titanium Alloy (Ti-6Al-4V) or PEEK-OPTIMA
Suture Material: Ultra-High-Molecular-Weight Polyethylene (UHMWPE)
Button Dimensions: Available in various lengths (e.g., 12mm, 15mm, 20mm) and widths (e.g., 3mm-5mm) to suit different anatomies
Suture Loop Lengths: Available in customizable continuous loop lengths (e.g., 15mm-60mm)
Suture Configuration: Pre-loaded with multiple strands (typically 2, 4, or 5) to create a tensionable loop
Suture Color: Typically White or Blue
Sterility: Sterilized by Gamma Irradiation or EO Gas
Achieve robust and versatile ligament reconstruction and syndesmosis fixation with our premium Suture Button, a suspensory fixation device engineered for strong, reliable soft tissue-to-bone healing. This innovative implant system, consisting of a low-profile metal button pre-loaded with high-strength suture, is primarily indicated for ACJ reconstruction, syndesmosis stabilization, and various tendon/ligament reattachment procedures. Designed for orthopedic and sports medicine surgeons seeking minimally invasive techniques, our Suture Button eliminates the need for large interference screws, preserves bone stock, and provides consistent, tensionable fixation for predictable postoperative recovery.
Strong, Cortical Suspensory Fixation: Unlike traditional screw fixation that relies on bone quality, our Suture Button provides rigid cortical fixation by resting against the outer bone cortex. This creates a strong, reliable suspension bridge for the graft, minimizing the risk of graft slippage and allowing for earlier, more aggressive rehabilitation protocols.
Low-Profile, Anatomic Button Design: The implant features a smooth, rounded, and ultra-low-profile button that sits flush against the bone. This design minimizes soft tissue irritation and the need for subsequent hardware removal, improving patient comfort and reducing the risk of postoperative complications .
High-Strength, Pre-Loaded Suture Loops: The button comes pre-loaded with multiple loops of ultra-high-molecular-weight polyethylene (UHMWPE) suture, known for its exceptional tensile strength and abrasion resistance. This provides a robust and wear-resistant interface for securing grafts or repairing ligaments, ensuring long-term fixation integrity.
Simplified, Tensionable Technique: The suture-button construct allows for precise graft tensioning and fixation through small bone tunnels. This facilitates a less invasive surgical approach, reduces operating time, and gives the surgeon ultimate control over final graft tension, leading to improved biomechanical outcomes.
CE Marking: Conforms with the European Medical Devices Regulation (MDR), ensuring safety and performance for the European market.
ISO 13485 Certification: Our manufacturing facility is certified to international standards for medical device quality management systems.
| Parameter | Detail | Notes |
|---|---|---|
| Device Type | Suspensory Cortical Fixation Button | For ligament/tendon reconstruction |
| Button Material Grade | Ti-6Al-4V ELI or PEEK-OPTIMA LT1 | Medical grade, high strength, radiolucent (PEEK) options |
| Button Thickness | 1.0mm - 2.0mm | Ultra-low profile to minimize irritation |
| Button Hole Configuration | 2, 3, or 4 suture holes | Allows for multiple suture passes and tensioning options |
| Suture Composition | 100% UHMWPE | High knot strength and creep resistance |
| Suture Tensile Strength | > 300 N (varies by configuration) | Exceeds physiological loads for most applications |
| Loop Construction | Continuous, pre-sized loop | No knot tying required; self-reinforcing |
| Primary Indications | ACL/PCL Reconstruction, Syndesmosis Fixation, AC Joint Reconstruction, Lisfranc Repair, Tendon Reattachment | Versatile for various orthopedic procedures |
| Bone Tunnel Diameter | Typically 4.0mm - 6.0mm | Minimizes bone loss compared to interference screws |
WELL TRUST advantages
1. Full certification: CE, ISO:13485, Free Sale Certificate
2. Rich experienced in manufacturing and exportation since 2005.
3. 3-7 days delivery for most product models with regular stock.
4. Resonable price: more competitive than competitors, gives the credit to strict and high efficient team management.
5. ODM & OEM service support for most of product lines .
6. Rapidly developing distribution network and comprehensive after-sales service.
