Explore our flagship, globally certified orthopedic implant lines engineered with Swiss-lathe precision for sports medicine, arthroplasty, and trauma procedures.
Manufactured exclusively from ultra-pure Titanium Alloy (Ti-6Al-4V ELI Grade 23 conforming to ASTM F136). High strength-to-weight ratio ensures zero cytotoxicity, minimal magnetic resonance imaging (MRI) artifact formation, and rapid osseointegration at bone tunnel contact interfaces.
Engineered with micro-polished, rounded thread flanks specifically calibrated to eliminate soft tissue laceration during insertion. Provides uniform compression across hamstring graft strands and soft tissue-to-bone contacts, yielding pull-out strength exceeding 850 N.
Fabricated on 5-axis Citizen Swiss CNC lathes within ISO Class 7 cleanrooms. Fully cannulated architecture (compatible with 1.5mm / 2.0mm Nitinol guide wires) guarantees coaxial trajectory alignment, eliminating tunnel wall blowout during insertion.
| Biomaterial Criteria | Titanium Alloy (Ti-6Al-4V ELI) | PEEK (Polyetheretherketone) | Bioabsorbable (PLGA / TCP) |
|---|---|---|---|
| Ultimate Pull-Out Strength | > 850 N (Superior) | ~ 650 N (Moderate) | ~ 450-550 N (Lower initial) |
| Graft Laceration Risk | Extremely Low (Blunt Thread Geometry) | Low | Moderate to High (Brittle edge risk) |
| Torsional Shear Resistance | Maximum (Zero Socket Stripping) | High (Socket deformation potential) | Low (Risk of head shearing during dense bone insertion) |
| Inflammatory Tissue Response | Negligible (Inert oxide layer) | Inert | Variable (Acidic degradation by-products) |
| Long-Term Revision Compatibility | predictable overtap or trephine removal | Requires specialized drill removal | Unpredictable tunnel cyst creation |
In-depth overview of the surgical demand, healthcare tender dynamics, and clinical application scenarios for titanium interference screws across Brazil's healthcare ecosystem.
Brazil represents the largest orthopedic device market in Latin America. Driven by high sports participation (particularly football, Brazilian Jiu-Jitsu, and beach sports), anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) injury rates remain high. Both public healthcare systems (SUS - Sistema Único de Saúde) and major private hospital networks (e.g., Rede D'Or São Luiz, Hospital Albert Einstein, Amil, and Bradesco Saúde) are increasingly seeking high-performance, cost-efficient implants to mitigate expanding surgical backlogs.
As a top tier China-based manufacturer, our facility delivers orthopedic implants engineered to international standards at factory-direct pricing, positioning Brazilian hospital procurement agencies and surgical distributors to optimize cost structures without sacrificing surgeon satisfaction or clinical safety.
In Brazilian orthopedic centers across São Paulo and Rio de Janeiro, autologous graft choices vary between Bone-Patellar Tendon-Bone (BTB) and quadrupled Semitendinosus/Gracilis (HT) grafts. Titanium interference screws provide immediate rigid mechanical fixation for femoral and tibial tunnels. The self-tapping profile reduces surgical step counts, shortening tourniquet times during high-volume day-surgery lists.
For complex revision surgeries involving bone tunnel enlargement, surgical teams utilize our expanded diameter titanium screws (up to 11mm diameter x 35mm length). Combined with allografts or synthetic graft augmentation, the high structural modulus of medical grade titanium stabilizes the revision construct where bioabsorbable screws risk early breakdown or aseptic tunnel osteolysis.
Navigating Brazil's stringent regulatory landscape (Agência Nacional de Vigilância Sanitária) requires complete technical file transparency, factory audit documentation, and rigorous international quality certifications.
We provide complete technical dossiers compliant with ANVISA RDC 751/2022 framework for Class III implantable medical devices. Technical files include biocompatibility reports (ISO 10993 series), mechanical static and dynamic fatigue test results (ASTM F543 / ISO 6475 standard test methods for medical bone screws), and validation documentation for gamma sterilization processes.
Our manufacturing campus operates under a fully integrated ISO 13485:2016 Quality Management System. We fully support Brazilian importers and official distributors during Brazilian Good Manufacturing Practices (BGMP / CBPF) inspection audits conducted by ANVISA inspectors, streamlining product registration timelines.
Leveraging established logistics channels to major Brazilian entry hubs (Port of Santos, Aeroporto Internacional de Guarulhos - GRU, and Viracopos), our export team ensures precise documentation under Mercosur Harmonized System Code NCM 9021.39.91. We supply Certificate of Origin (Form A/CO), Bills of Lading, and localized sterile labeling in Portuguese.
Since 1992, our facility has evolved into a global leader in orthopedic osteosynthesis and sports medicine implant production. Spanning a 62,391 square foot state-of-the-art campus, our high-precision production infrastructure integrates 5-axis CNC machining, high-speed Swiss-type lathes, multi-axis Integrax systems, and automated optical coordinate measuring machines (CMM) achieving dimensional tolerances within +/- 0.005mm.
For medical device brand owners and regional Brazilian distributors, we offer end-to-end OEM manufacturing services. This includes custom head geometry design (Torx Star Drive, Hexagonal Socket, Square Socket), specific thread pitch variations, custom anodization colors (gold, blue, green titanium color-coding by diameter), laser marking of SKU numbers and lot codes, and customized blister packaging ready for sterilization.
Key technical, regulatory, and commercial queries addressed for medical buyers serving the Brazilian and South American markets.
All our titanium interference screws are manufactured strictly from medical-grade Titanium Alloy Ti-6Al-4V ELI (Extra Low Interstitial), conforming to ASTM F136 and ISO 5832-3 standards. Every shipped batch includes full raw material chemical analysis and tensile test certification (Mill Test Report) linked directly to the lot number laser-etched on the implant packaging.
We supply a complete ANVISA-compliant technical registration dossier (Dossiê Técnico). This includes cleanroom environmental monitoring logs, ISO 13485 certification copies, mechanical fatigue test reports according to ASTM F543 standards, bioburden and sterility validation files, and customized product artwork formatted with Portuguese labeling in compliance with RDC 751/2022 requirements.
Our standard titanium interference screw range covers diameters from 7.0mm to 11.0mm (in 1.0mm increments) and lengths from 20mm to 35mm. Screws feature a fully cannulated core (compatible with standard 1.5mm / 2.0mm Nitinol guide pins) and are available in both standard Hexagonal sockets and Star/Torx drive patterns to maximize drive torque transfer without stripping.
Yes. We supply dedicated reusable arthroscopic instrument sets crafted from German stainless steel. These include cannulated screwdrivers, tunnel reamers, bone tunnel notches, tendon harvesters, and Nitinol guide wires engineered for exact dimensional synergy with our titanium interference screw series.
For standard catalog SKUs, our flexible MOQ allows distributors to sample mixed sizing combinations. Typical production and dispatch lead times range from 15 to 30 days depending on whether bulk non-sterile packaging or validated sterile blister packaging is selected. Express airfreight via DHL/FedEx or cargo routes to GRU/Viracopos airports ensures prompt delivery.
Absolutley. Electrochemical anodization processes allow us to offer color-coded titanium screws (e.g., Pink for 7mm, Green for 8mm, Blue for 9mm, Gold for 10mm). Color-coding streamlines intraoperative size identification for surgical theater teams, reducing scrub nurse prep times.
Partner with China's leading exporter of precision titanium interference screws and arthroscopy systems. Request complete product catalogs, CAD specifications, and factory-direct wholesale pricing for the Brazil market today.