CE Certification Bone Screws Orthopedic Supplier & Pricelist

Cortical bone screws are engineered for dense diaphyseal bone. They feature a finer pitch (typically 1.0mm to 1.75mm), a smaller outer-to-core diameter ratio, and a higher thread density along the shaft to engage the compact lamellar osteon structures without splitting bone. Cancellous bone screws are designed for porous metaphyseal and epiphyseal bone. They feature a wide buttress thread with deeper tooth depth, larger pitch (typically 2.75mm to 3.25mm), and an aggressive cross-sectional core that compresses spongy bone trabeculae to maximize axial pull-out resistance (often exceeding 1,800 N under ASTM F543 tensile testing).

Under the EU MDR 2017/745 framework, long-term surgically invasive implants such as bone screws and spinal hardware fall under Class IIb (Rule 8). Our quality infrastructure maintains an ISO 13485:2016 audited Quality Management System, active CE Mark certification audited by UDEM, and full Technical Documentation dossiers (STED). These files incorporate ISO 14971 risk management, ISO 10993 biocompatibility testing, ISO 11607 sterile barrier validation, and robust Clinical Evaluation Reports (CER) with active Post-Market Clinical Follow-Up (PMCF).

All bone screws are machined exclusively from certified medical-grade titanium alloy (Grade 5 Ti-6Al-4V ELI conforming to ASTM F136 / ISO 5832-3) or vacuum-arc remelted surgical stainless steel (316LVM conforming to ASTM F138 / ISO 5832-1). Every raw bar stock shipment arrives with raw material mill test certificates (MTC) documenting chemical composition, tensile yield strength, and microstructural grain sizing. Each production batch is assigned a unique laser-etched laser lot number, establishing bi-directional tracking spanning CNC cutting, ultrasonic cleaning, cleanroom packaging, sterilization, and hospital receipt.

StarDrive (hexalobular/Torx-compatible) drive recesses distribute torsional torque across six broad vertical contact lobes rather than concentrating stress on the sharp corners of a hexagon. This dramatically reduces stripping, cam-out, and driver slippage during high-torque insertion into dense bone. Biomechanical tests demonstrate that StarDrive recesses permit up to 45% higher torsional transmission before recess deformation, providing superior tactile feedback and preventing stripped screw heads inside the sterile surgical field.

Yes. Beijing ZhongAnTaiHua Technology Co., Ltd. (ZATH) provides end-to-end OEM and ODM contract manufacturing. We can customize screw length ranges, thread profiles, cannulation diameters, self-tapping cutting flute geometries, surface finishes (Type II anodization, micro-blasting), and laser markings (distributor logo, product code, lot number). We also engineer custom sterilization packaging boxes, blister trays, and matching surgical instrument sets to client specifications.

We provide both configurations based on distributor requirements. Our pre-sterilized offerings are packaged within validated ISO Class 7/8 cleanrooms using DuPont™ Tyvek® double-blister sterile barrier systems, sterilized via Gamma irradiation or Ethylene Oxide (EO), and carry a 5-year validated shelf life. Non-sterile options are bulk-packaged in protective multi-compartment containers designed for autoclave steam sterilization within standard hospital sterilization trays.

Standard export express shipments are dispatched via international courier partners including DHL Express, FedEx Priority, TNT, UPS, and EMS. Typical transit delivery times range from 4 to 6 business days to European, Middle Eastern, Latin American, and Southeast Asian logistics hubs, supported by full export documentation (Commercial Invoice, Packing List, Certificate of Origin, MTC).