Axiora Medical Axiora Medical

OEM/ODM Maxillofacial Plating Systems Supplier & Exporter

High-Precision Cranio-Maxillofacial (CMF) Fixation Solutions & Customized Orthopedic Implants meeting ISO 13485 & CE Standards

Clinical Precision in Maxillofacial Reconstruction: Whitepaper Overview

Reconstruction within the craniomaxillofacial (CMF) complex demands unprecedented mechanical integrity, micro-tolerance dimensions, and long-term bio-compatibility. The human skull, face, and jaw constitute an intricate assembly of structural units subject to continuous functional stress during mastication, speech, and respiratory kinetics. Axiora Medical Technology (China) Co., Ltd. sits at the forefront of this surgical discipline. We engineer, manufacture, and export surgical-grade osteosynthesis implants. Specifically, our titanium maxillofacial plating systems are optimized for rigid internal fixation, trauma recovery, orthognathic correction, and pediatric craniofacial reconstruction.

Our deep-level OEM and ODM services utilize state-of-the-art CNC Swiss machining centers, high-tolerance milling installations, and automated electrochemical anodization setups to output medical-grade titanium (Ti-6Al-4V ELI / Ti Grade 4) and premium polymeric materials like PEEK. Supported by 86 dedicated R&D engineers and 48 quality control specialists, we implement rigorous incoming-material validation and 100% finished-product dimensional audits. Through these comprehensive methods, we ensure that every plate, mesh, and locking screw we manufacture is aligned with international clinical standards.

15+
Years Industry Experience
18.6k m²
Modern Production Area
86
R&D Engineers & Designers
48
QC Inspectors & Auditors

Axiora Corporate Credentials & Specifications

Item Details
Company Name Axiora Medical Technology (China) Co., Ltd.
Brand Axiora
Website www.axioraortho.com
Established 2017
Factory Area 18,600 m²
Annual Export Revenue USD 26 Million
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 Quality Control Professionals
Business Type Manufacturer & Exporter (OEM/ODM/OBM)
Main Markets Europe, North America, Middle East, Southeast Asia, South America, Africa
Supply Chain Partners 1,120 Globally Networked Logistics and Raw Material Providers
R&D Capability Independent Product Design, Finite Element Analysis (FEA), Reverse Engineering, OEM & ODM Prototyping
Customization Options Laser Logo Marking, Private Labeling, Sterile/Non-Sterile Packaging, Custom Plate Geometry, Titanium Color Anodizing
New Products Released Last Year 126 New SKUs & Product Iterations

Cranio-Maxillofacial Biomechanics & Material Science

Modern maxillofacial surgery demands plating systems that balance structural support with physiological comfort. Because facial bones are thinner and subject to multi-directional forces, conventional orthopedic trauma plates are inadequate. Instead, CMF fixation requires specialized micro, mini, and mid-sized plating profiles (typically ranging from 1.0mm, 1.3mm, 1.5mm, 2.0mm to 2.4mm screw diameter designs) to minimize hardware palpability while ensuring skeletal stability.

Axiora uses ultra-purified medical titanium, primarily ISO 5832-2 Class 4 Pure Titanium (for high-bend contourability) and ISO 5832-3 Ti-6Al-4V ELI (for areas requiring superior fatigue strength and pull-out resistance). Through electro-anodization, our implants receive a controlled oxide layer. This layer color-codes the systems by thickness for easier intraoperative identification while enhancing passivation to prevent galvanic corrosion and ensure optimal osseointegration.

Technological Roadmap: The Evolution of CMF Implants

Phase I

Micro & Mini Systems (1.0mm - 2.0mm)

Development of malleable, low-profile plating patterns for orbital floor repair, midface trauma, and orthognathic advancement, minimizing anatomical prominence.

Phase II

Locking & Variable Angle Technology

Implementation of lockable screw-to-plate configurations to prevent plate-to-bone compression, preserving periosteal vascularization and boosting construct stability.

Phase III

Patient-Specific Implants (PSI) & PEEK

Integrating 3D CAD/CAM models from patient CT data to mill customized PEEK or 3D-print (selective laser melting) titanium meshes for reconstruction of major defects.

China Factory 4.0: Lean Production & Process Validation

Axiora runs a digital-first, vertically integrated manufacturing plant spanning 18,600 m². We have automated our production floor with Swiss CNC longitudinal cutting lathes, precise multi-axis grinding equipment, and class-10,000 cleanrooms for sterile packaging. This digital integration allows us to trace each raw batch of titanium back to its origin certificate, maintaining a transparent auditing trail for medical authorities like the FDA, NMPA, and European notified bodies.

Below, we detail our step-by-step production cycle. This systematic approach ensures that every implant is manufactured with high consistency, dimensional accuracy, and clean surfaces, maintaining our standard of zero-defect medical-grade shipments.

Raw Material Inspection
Raw Material
Longitudinal Cutting
Longitudinal Cutting
CNC Machining
CNC Machining
Surface Polishing
Polishing
Ultrasonic Washing Stage 1
Ultrasonic Washing 1
Grinding Processing
Grinding
Sand-Blasting Finish
Sand-Blasting
Penetrant Crack Detection
Penetrant Testing
Electrochemical Anodizing
Anodizing
Ultrasonic Washing Stage 2
Ultrasonic Washing 2
Outgoing Quality Control
OQC Inspection
Aseptic Sterile Packing Room
Aseptic Packing Room
Packing Line Processing
Packing Line
Temperature Controlled Storage
Storage & Logistics
Longitudinal Cutting Lathe Machinery
Longitudinal Cutting Lathe
CNC Processing Station
CNC Machinery
Polishing Machinery Section
Polishing Machine
Ultrasonic Washing Unit System
Ultrasonic Washing Unit
Grinding Machinery System
Grinding Machine
Sand-Blasting Machinery Units
Sand-Blasting Machine
Anodizing Processing Line
Anodizing Machine
Penetrant Testing Lab
Penetrant Testing Room
Mechanical Endurance Tester
Endurance Tester
Polymer and Metal Aging Tester
Aging Tester

Global Regulatory Compliance & Local Support

Navigating medical device registrations globally is complex. Regulatory frameworks like the EU MDR 2017/745 and FDA 510(k) place high demands on technical documentation and clinical evaluation reports. Axiora helps distributors and OEM partners streamline registration by providing comprehensive regulatory support files.

We provide complete documentation, including biological evaluation reports (ISO 10993 series), steam sterilization validations (ISO 17665), packaging integrity tests, and cleanroom environmental records. These resources are designed to expedite local regulatory clearance for import markets worldwide.

Our on-site engineering team handles drawing interpretation and manufacturing adjustments, ensuring your customized orders transition smoothly from prototype to clinical validation.

Supply Chain Resiliency & Strategic Sourcing

In today's medical supply chain, volatility in raw materials and logistics is a major risk. Axiora helps partners build resilient procurement programs. By holding large reserves of certified medical titanium rod stock and maintaining partnerships with 1,120 active supply partners, we protect our clients from sudden price spikes and material shortages.

We offer flexible pricing options, raw material forecasting models, and support for high-volume public tenders. Additionally, we run a reliable logistics network to manage air cargo, customs clearance, and cold-chain shipments, helping you avoid port delays.

? Frequently Asked Questions (FAQ) - OEM & ODM Procurement

Q1: What grades of titanium are utilized in your maxillofacial plating systems?
We construct our maxillofacial implants using ISO 5832-2 Class 4 Pure Titanium (Gr 4) and ISO 5832-3 Ti-6Al-4V ELI (Grade 5). Pure Titanium Gr 4 provides excellent ductility for plates that require shaping during surgery. Ti-6Al-4V ELI is used for locking screws and reconstruction plates that require high load-bearing capacity.
Q2: How do you guarantee the quality and tolerances of custom ODM bone plates?
Our factory employs multi-axis CNC Swiss-type grinding and milling machines, allowing us to maintain tolerances within ±0.01mm. Every production run undergoes Coordinate Measuring Machine (CMM) testing, tensile strength profiling, and surface roughness checks. We also perform penetrant testing to verify there are no micro-cracks in the metal.
Q3: Can you assist with registrations under EU MDR or US FDA 510(k)?
Yes, our dedicated regulatory department assists distributors with these filings. We provide technical files, ISO 13485 test data, biocompatibility reports (ISO 10993), sterilization validation protocols, and trackable raw material documentation to help streamline your local registration process.
Q4: What is the typical lead time for custom prototype runs and bulk OEM runs?
Initial CAD modeling and prototype samples are typically completed within 15–20 days after drawing sign-off. Bulk OEM manufacturing runs average 30–45 days, depending on order size and anodization finishes.
Q5: What sterile packing options do you provide?
We offer medical-grade sterile blister packaging, Tyvek pouch sealing, and customized non-sterile kit packaging. All sterile processes are executed inside our Class-10,000 cleanroom facilities.