Axiora Medical
Axiora Medical
In complex spinal reconstruction and spinal fusion surgeries, implant stability is the most decisive factor for successful osteointegration and long-term therapeutic outcomes. Monoaxial pedicle screws, designed with a fixed perpendicular axis relative to the locking head, offer unparalleled mechanical leverage and rigidity compared to their polyaxial and uniplanar counterparts. This structural integrity is primary when performing deformity corrections, such as severe scoliosis, kyphosis, and post-traumatic spinal stabilization, where rotational control is crucial.
Axiora Medical, as a leading global manufacturer, builds upon decades of orthopedic engineering expertise. We utilize high-strength Ti-6Al-4V ELI (Grade 23) titanium alloy to manufacture monoaxial pedicle screws. This material delivers superior fatigue resistance, biocompatibility, and radiographic imaging clarity. By maintaining strict control over manufacturing tolerances down to microns, our implants ensure seamless biomechanical lockups, eliminating the risk of thread-stripping or assembly failure during high-torque insertion.
Spinal surgeries have evolved from general stabilization to customized anatomical reconstruction. Modern surgical protocols demand hybrid instrumentation where monoaxial screws form the rigid foundation of spinal constructs, supplemented by polyaxial screws for flexible anatomy tracking.
Axiora Medical Technology (China) Co., Ltd. is a professional manufacturer specializing in the research, development, production, and global supply of high-quality orthopedic implants and surgical instruments. Our product portfolio covers trauma fixation systems, spinal implants, joint reconstruction solutions, sports medicine products, and related orthopedic surgical instruments.
Established with a commitment to innovation and precision manufacturing, Axiora integrates advanced CNC machining, automated production lines, and strict quality management systems to deliver reliable products that meet international standards. Our experienced engineering team continuously develops innovative solutions to support surgeons and healthcare providers worldwide.
With strong OEM and ODM capabilities, we provide customized manufacturing services according to customers' drawings, samples, and technical requirements. From product design and prototyping to mass production and packaging, our integrated manufacturing process ensures consistent quality, competitive pricing, and on-time delivery. Today, Axiora exports its orthopedic products to customers across Europe, North America, South America, the Middle East, Southeast Asia, and Africa, building long-term partnerships with medical device distributors, brand owners, hospitals, and healthcare organizations around the world.
| Corporate Parameter | Details & Compliance Specifications |
|---|---|
| Company Name | Axiora Medical Technology (China) Co., Ltd. |
| Brand | Axiora |
| Website | www.axioraortho.com |
| Established | 2017 |
| Factory Area | 18,600 m² |
| Export Experience | 8 Years |
| Quality Inspection | 100% Finished Product Inspection & Incoming Material Inspection |
| Product Inspection Methods | Coordinate Measuring Machine (CMM), Tensile Testing, Hardness Testing, Surface Roughness Inspection, Salt Spray Testing |
| Quality Control Staff | 48 Dedicated Specialists |
| Business Type | Manufacturer & Exporter (OEM/ODM) |
| Main Markets | Europe, North America, Middle East, Southeast Asia, South America |
| Customization Options | Logo Printing, Private Label, Custom Packaging, Product Design, Material Selection, Drawing-Based Manufacturing |
| New Products Released Last Year | 126 FDA/CE compliant products |
Quality is the cornerstone of patient safety. Axiora maintains 100% trace-ability for every titanium raw rod down to the finished aseptic product. Walk through our clinical production process below.
Navigating the medical device regulatory environment is highly challenging. The transition from MDD to EU MDR 2017/745 in Europe, combined with regional regulatory barriers in LATAM (ANVISA) and APAC markets, means sourcing certified products is crucial for distributors. Axiora Medical actively resolves these challenges by providing complete regulatory technical dossiers.
All our monoaxial pedicle screws are fully CE and ISO 13485:2016 certified. Every batch is supported by raw material mill certificates, biocompatibility test results (ISO 10993), and biomechanical testing reports under ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
Furthermore, we support local registrations around the world. We offer comprehensive translation services for technical portfolios, clinical evaluation reports (CER), and support local distributor audits by coordinating virtual or on-site inspections.
To maintain leadership in spinal fixation technology, our R&D department continues to innovate. The future of pedicle instrumentation focuses on smart surfaces, active bone integration, and seamless integration with robotic surgery platforms.
Explore clear, technical answers to common questions about regulatory approval, material characteristics, and OEM capability.
