Axiora Medical Axiora Medical

Custom OEM Tibial Trays Manufacturer & Factory

Precision-Engineered Implant Components & Specialized Surgical Solutions for Global Orthopedic Medical Devices Brands

The Biomechanical Role & Design Science of Tibial Trays

In Total Knee Arthroplasty (TKA), the tibial tray acts as the foundational load-bearing baseplate. It receives and redistributes dynamic physiological loads from the femoral component down to the cancellous and cortical bone of the proximal tibia. Achieving long-term implant survivorship depends heavily on mitigating micromotion, reducing stress shielding, and ensuring precise mechanical lock interfaces with the ultra-high-molecular-weight polyethylene (UHMWPE) inserts.

As a leading OEM tibial trays factory, Axiora Medical Technology designs and manufactures custom tibial components. We solve critical biomechanical challenges, including optimizing cruciate-retaining (CR) and posterior-stabilized (PS) geometry, refining sagittal stability, and integrating bone-conserving keels. Through advanced metal finishing and porous coating technologies, we ensure that every custom tibial tray provides immediate initial mechanical stability and promotes long-term biological fixation.

15+
Years Industry Experience
86
R&D Engineers on Staff
18.6K m²
Modern Production Facility
100%
Traceability & Inspection

Axiora Corporate Overview

Empowering Global Orthopedic Brands with ISO-13485 Certified Medical Component Manufacturing

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.

Item / Parameter Details & Capabilities
Company Name Axiora Medical Technology (China) Co., Ltd.
Brand Axiora
Website www.axioraortho.com
Established 2017
Factory Area 18,600 m² (Class 10,000 Cleanroom & Precision CNC Facility)
Annual Export Revenue USD 26 Million
Export Experience 8 Years serving Europe, Americas, and APAC regions
Industry Experience 15 Years in Orthopedic Implants manufacturing
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 QA/QC Specialists
Business Type Manufacturer & Exporter (Full OEM/ODM support)
Main Markets Europe, North America, Middle East, Southeast Asia, South America
Supply Chain Partners 1,120 global raw material suppliers and logistics partners
Main Customer Types Medical Device Brands, Importers, Distributors, Hospitals, Government Procurement Projects
R&D Capability Independent Product Development, Reverse Engineering, OEM & ODM Solutions
Customization Options Logo Printing, Private Label, Custom Packaging, Product Design, Material Selection, Drawing-Based Manufacturing
New Products Released Last Year 126 products added to our trauma, spine, and joint catalogs
R&D Engineers 86 highly qualified biomedical and industrial design engineers

Vertical Production & Processing Pipeline

Witness how we transform medical-grade alloys into ultra-precise implantable tibial components.

Step 01 Raw Material Inspection
Raw Material
Step 02 Longitudinal Cutting
Longitudinal Cutting
Step 03 CNC Machining
CNC
Step 04 Polishing
Polishing
Step 05 Ultrasonic Washing 1
Ultrasonic Washing 1
Step 06 Grinding
Grinding
Step 07 Sand-Blasting
Sand-Blasting
Step 08 Penetrant Testing
Penetrant Testing
Step 09 Anodizing
Anodizing
Step 10 Ultrasonic Washing 2
Ultrasonic Washing 2
Step 11 OQC (Outgoing Quality Control)
OQC
Step 12 Aseptic Packing Room
Aseptic Packing Room
Step 13 Packing Line
Packing Line
Step 14 Storage & Logistics
Storage

State-of-the-Art Production & Testing Facilities

Ensuring dimensional integrity, long-term fatigue limit verification, and absolute sterility.

Longitudinal Cutting Lathe
Longitudinal Cutting Lathe
CNC Mill
CNC Machining
Polishing Machine
Polishing Machine
Ultrasonic Washing Unit
Ultrasonic Washing Unit
Grinding Machine
Grinding Machine
Sand-Blasting Machine
Sand-Blasting Machine
Anodizing Machine
Anodizing Machine
Aseptic Packing Room Facility
Aseptic Packing Room
Penetrant Testing Room
Penetrant Testing Room
Endurance Tester
Endurance Tester
Aging Tester
Aging Tester

Biomechanical Engineering & Material Optimization

Providing technical information increment on materials, locking mechanisms, and interface coatings.

Biocompatible Materials & Microstructures

Modern total knee systems demand baseplates manufactured from materials that mirror bone elasticity and offer superior wear resistance. At Axiora, we process high-grade titanium alloys (Ti6Al4V ELI as per ASTM F136) and cobalt-chromium-molybdenum alloys (CoCrMo as per ASTM F75).

Titanium baseplates are highly favored for cementless primary TKA due to their lower modulus of elasticity compared to CoCrMo, which dramatically lowers the risk of bone resorption through stress shielding. Additionally, we integrate advanced physical vapor deposition (PVD) coatings and porous plasma spray titanium (VPS) to generate open-pore networks that stimulate physiological osseointegration.

Backside Micromotion Reduction & Locking Mechanisms

An critical factor in premature TKA revision surgery is wear of the UHMWPE insert, often accelerated by backside micromotion against the tibial tray. We address this using custom CNC machining tolerances within the ±5 to 10-micron range.

Our engineered modular locking mechanisms employ dual peripheral snap-fits coupled with a central stabilization peg, ensuring high-strength capture. The tibial baseplate's proximal surface is polished to an ultra-low roughness (Ra < 0.05 μm), virtually eliminating abrasive wear on the bottom of the plastic insert during cyclical compression-torsion load cycles.

Supply Chain Advantages of Our China OEM Factory

Why global orthopedic OEMs choose Axiora for scalable, cost-optimized, and risk-resilient manufacturing.

Industrial Clustering

Located in China’s premier medical manufacturing hub, Axiora enjoys direct access to domestic, certified medical titanium melt shops, rapid-tooling casting foundries, and sterile packaging specialized service providers. This allows us to reduce raw material lead times and transition from drawing approval to physical validation in weeks rather than months.

Advanced Cost Engineering

Leveraging highly automated 5-axis CNC machining rows and advanced ultrasonic washing setups, we dramatically lower unit production costs without making quality compromises. Our high export volume enables us to negotiate competitive shipping rates and pass on systemic savings directly to our global OEM brand partners.

End-to-End Vertical Integration

Unlike many contract workshops, Axiora hosts all key processes—raw material metallurgical validation, Swiss-lathe cutting, milling, polishing, anodizing, penetrant testing, and aseptic pouch sealing—under one roof. This minimizes supply chain gaps and prevents quality contamination risks.

Global Regulatory Compliance & Localized Support

Meeting the strict registration requirements of US FDA, EU CE MDR, and global healthcare systems.

ISO 13485 & Class III Regulatory Dossier Support

We manage product master files in accordance with international medical standards. For global medical brands aiming to submit CE Class III or FDA 510(k) applications for their total joint reconstruction lines, we provide full support by sharing raw material certificates, chemical analysis results, mechanical stress simulations, and biological compatibility test datasets.

Comprehensive Mechanical Verification testing (ASTM F1800)

Every newly developed OEM tibial tray is subjected to rigorous dynamic fatigue testing. Using our advanced endurance testers, we apply load configurations up to 10 million cycles to confirm that the baseplate will not experience structural or mechanical fatigue fracture under intense physiological conditions.

Localized Custom Sterile Packaging & Fast-Track Delivery

We offer sterilized, double-barrier pouch configurations in accordance with ISO 11607, ensuring the implants can go straight into hospitals and surgical centers. Our global distribution channels support fast shipping to direct warehouses in Europe, South America, North America, and APAC.

Target Application Scenarios & Global Trends

Adapting to the future of joint arthroplasty: 3D printing, custom geometries, and robot-assisted surgery.

Primary & Complex Revision TKA

Our customized tibial trays accommodate various levels of bone loss. In revision total knee arthroplasty, we offer modular stem extensions and tibial wedges, providing surgeons with the tools to secure stable fixation despite severe proximal bone loss.

Additive Manufacturing & Porous Materials

As technology advances, additive manufacturing (3D printing) of titanium structures is becoming the standard. Axiora's R&D department is leading the way by developing integrated trabecular titanium baseplates that mimic the structure of human bone, accelerating osteointegration and eliminating the need for bone cement.

Veterinary Joint Replacement Options

With the demand for veterinary orthopedics increasing, we leverage our manufacturing systems to scale down human joint designs. This allows us to supply veterinary implants, including canine total knee replacement prosthetics, to clinics and animal health brands worldwide.

Frequently Asked Questions

Get answers to critical technical and logistical questions regarding our tibial tray OEM manufacturing services.

Q: Which raw materials do you use for your tibial trays?
We use high-grade Ti6Al4V ELI (ASTM F136) and CoCrMo (ASTM F75) alloys sourced from medical-grade suppliers. Every batch undergoes spectral analysis and tensile testing to confirm full compliance before processing.
Q: How does Axiora ensure the locking mechanism prevents backside wear?
We use precision multi-axis CNC machines to maintain a dimensional tolerance of ±5-10 μm on the locking tab and guide slots. We also polish the metal's top surface to Ra < 0.05 μm, reducing friction-induced wear on the polyethylene insert.
Q: Can you manufacture custom tibial trays from 2D/3D CAD drawings?
Yes. Our team of 86 R&D engineers works with IGES, STEP, and DWG files. We also provide reverse engineering services to optimize existing implant geometries and resolve issues like micro-motion.
Q: What quality and regulatory standards do you conform to?
Our facilities are fully certified to ISO 13485:2016. We conduct 100% inspection on critical dimensions using CMMs, and maintain complete manufacturing records to ensure total lot traceability.
Q: Do you offer porous coatings for cementless fixation?
Yes. We provide vacuum plasma spraying (VPS) of titanium powder, bead sintering, and are also developing 3D-printed trabecular titanium coatings to facilitate rapid bone ingrowth.
Q: What is your typical lead time for custom production runs?
Prototypes are typically completed within 3 to 4 weeks. High-volume production runs generally require 8 to 12 weeks, depending on order size and custom packaging requirements.

Accelerate Your Orthopedic Product Development

Partner with an ISO 13485 certified China manufacturer to experience high-precision manufacturing, reliable quality control, and scalable supply chains.

Contact Our Engineering Team