Manufacturing

State-of-the-Art Precision Orthopedic Implant Manufacturing & OEM Solutions

Advanced Engineering

Research & Development Capabilities

Ortix Medical Devices Co., Ltd. integrates biophysical engineering, materials science, and medical expertise to develop world-class spine, trauma, and joint systems for global distributors.

Comprehensive R&D Platform

A multi-disciplinary research system covering biomechanics, titanium metallurgy, PEEK processing, clinical anatomy, and precision tooling design.

Collaborative Expert Team

Engineered by leading orthopedic specialists and supported by nearly 100 technical professionals—over 80% holding master's or doctoral degrees in biomedical engineering.

Strong R&D Investment

Continuous capital investment in 5-axis CNC machinery, high-precision CMM inspection, FEA stress simulation tools, and advanced fatigue testing apparatus.

Institutional Collaboration

Partnered with national spinal research studios, university biomechanical labs, and material research institutes to ensure clinically proven implant designs.

Quality Assurance

Uncompromising Quality & Compliance Guarantees

Every implant system engineered by Ortix Medical Devices Co., Ltd. undergoes rigorous quality verification aligned with global regulatory standards.

Zero Contamination Guarantee

ISO Class 7 ultrasonic cleaning and cleanroom packaging preventing particulate and bioburden contamination.

Speed-to-Clinic Turnaround

Streamlined production pathways reducing lead times for high-volume orders and customized OEM/ODM projects.

Embedded Regulatory Compliance

Full technical documentation support, material certificates, and test reports designed for rapid local registration.

100% Lot Traceability

Complete end-to-end traceability from raw medical grade titanium, PEEK, and stainless steel bars to finished sterile units.

Manufacturing Process

11-Step Precision Production Workflow

Our 60,000 m² facility features over 450 automated production machines operating under strict ISO 13485 protocols.

01

Raw Material Qualification

Top-grade Ti-6Al-4V ELI titanium, CoCrMo, PEEK OPTIMA, and surgical stainless steel. Chemical composition and physical stress tested per lot.

02

High-Precision Laser Cutting

Automated precision cutting delivering ±0.1mm length tolerances to optimize material yield and maintain physical bar structural integrity.

03

Wire EDM Machining

Slow-wire Electrical Discharge Machining creates intricate implant geometries and locking mechanisms with zero thermal distortion.

04

5-Axis CNC Machining Center

Swiss-type multi-axis turning and milling centers achieve sub-micron precision for pedicle screws, locking plates, and joint implants.

05

Optical & CMM Inspection

Automated optical measuring machines and 3D Coordinate Measuring Machines verify key dimension tolerances against CAD models.

06

Multi-Stage Ultrasonic Cleaning

Enzymatic degreasing and multi-tank ultrasonic pure water rinsing remove all cutting fluids, micro-particles, and residue.

07

Automated Surface Grinding

Robotic abrasive finishing refines anatomical contours and edges while monitoring surface roughness (Ra) standards.

08

Grit & Abrasive Blasting

Controlled media micro-blasting generates optimized surface roughness for enhanced osseointegration and coating adhesion.

09

Electropolishing & Buffing

Automated mechanical and electrochemical polishing creates ultra-smooth, mirror-like bio-compatible surfaces on load-bearing components.

10

Color Anodizing & Laser Marking

Electrolytic anodizing color-codes implants by size and diameter, followed by UDI laser engraving for complete post-market traceability.

11

Cleanroom Packaging & Sealing

Executed in ISO Class 7 cleanrooms using medical-grade Tyvek blister pouches or double pouch packaging for sterile barrier stability.

Orthopedic implant packing and export logistics
Global Operations

Packing & Delivery Solutions

Flexible international distribution support tailored to healthcare tenders and private label branding requirements.

Ortix Medical Devices Co., Ltd. provides end-to-end supply chain fulfillment. From initial protective packaging to customs clearance documentation, our logisticians ensure your inventory arrives safely and on schedule.

  • Air Freight for expedited urgent tenders
  • Sea Freight for optimized container bulk orders
  • Complete customs clearance invoice & packing list support

Talk to Ortix Medical Orthopedic Experts

We offer a full range of high-performance spine, trauma, joint, and sports medicine implants with complete surgical instrument sets, rapid delivery, and consistent lot-to-lot quality.