The global sports medicine landscape has witnessed a paradigm shift in Anterior Cruciate Ligament (ACL) reconstruction. As a leading ACL reconstruction buttons supplier and exporter, we recognize that the surgery is no longer just about graft placement; it is about "biological fixation" and "early mobilization."
Modern ACL buttons have evolved from simple titanium plates to sophisticated Adjustable Loop Devices (ALD) and Fixed Loop Devices (FLD). These components are critical in ensuring that the femoral fixation can withstand the tensile forces of post-operative rehabilitation. Our engineering focus lies in minimizing the "bungee effect" and "windshield wiper effect," which are common causes of tunnel widening and graft failure.
Utilizing high-tensile Titanium Grade 5 (Ti6Al4V ELI) to ensure maximum biocompatibility and ultimate tensile strength exceeding 1200N.
Our proprietary loop design allows for simplified graft tensioning and complete filling of the femoral tunnel, optimizing graft-to-bone healing.
Fully compliant with EU MDR 2017/745 and ISO 13485:2016, supporting hospital tenders across Europe, SE Asia, and South America.
KaiSo has established a complete Quality Assurance System to continuously fulfil the requirements according to ISO9001, 13485, CE, ranging from material procurement to design development and automated production processes. Our 22-year legacy in the orthopedic industry is built on the rigorous inspection of every single unit that leaves our facility.
| Feature | Fixed Loop Button | Adjustable Loop Button |
|---|---|---|
| Material | Titanium Alloy (Ti6Al4V) | Titanium Alloy + Ultra-High Molecular Weight Polyethylene (UHMWPE) |
| Deployment Method | Flip-on-exit femoral cortex | Flip-on-exit with dual-pull tensioning |
| Tunnel Coverage | Pre-measured sizes (15mm-50mm) | One-size-fits-all (adjustable up to 60mm) |
| Primary Indication | Standard ACL reconstruction | Revision ACL or All-inside technique |
We provide full documentation for government and private hospital tenders, including clinical evaluation reports and biocompatibility data.
With 59 R&D engineers, we offer "Light Customization" and "Graphic Processing" to meet specific market branding requirements.
Our transition to MDR (Medical Device Regulation) ensures long-term market access in the European Economic Area.
For large-scale distributors, we don't just supply products; we provide Integrated Surgical Kits. Our ACL reconstruction buttons are part of a broader ecosystem that includes Interference Screws, Graft Preparation Stations, and Precision Reamers. By sourcing a complete solution, healthcare providers reduce complexity and ensure instrument compatibility during critical surgical moments.
Currently, our main markets include South America (30%), Southeast Asia (20%), and Western Europe (20%), showcasing our ability to navigate diverse regulatory landscapes and clinical preferences.
The future of ACL reconstruction lies in Bio-absorbable Button Technology and Smart Implants. As a forward-thinking exporter, KaiSo is currently researching Magnesium-based alloys that provide temporary fixation and then dissolve, leaving only natural bone in the femoral tunnel. This eliminates the need for hardware removal and reduces long-term foreign body responses.
We are also integrating 3D-printing (Additive Manufacturing) for patient-specific orthopedic instruments, ensuring that every surgeon has the exact tool needed for complex anatomical variations.
| Founded | 2004-11-03 (22 Years of Stability) | Certifications | ISO13485, CE (93/42/EEC), MDR |
| Export Capability | 22 Years in Global Trade | R&D Strength | 59 Graduate Engineers |
| QA/QC Team | 69 Dedicated Inspectors | Inspection Method | 100% Inspection + Client Customization |
Titanium Grade 5 (Ti-6Al-4V) offers the best strength-to-weight ratio for medical implants. It is highly resistant to corrosion in the human body and is MRI-safe, which is crucial for post-operative imaging of the graft.
Every batch of loops undergoes cyclic loading tests and ultimate tensile strength (UTS) testing. We use medical-grade braided UHMWPE (Ultra-High Molecular Weight Polyethylene), which exhibits zero stretch and high fatigue resistance.
Yes, we offer "Light Customization" and "Sample Processing." This allows regional wholesalers to build their own brand identity while leveraging our 22 years of manufacturing expertise and certifications.
Depending on the volume and customization needs, we typically ship within 2-4 weeks. Our logistics partners ensure seamless delivery across our main markets in Europe and South America.
KaiSo Medical
