As a world-class OEM/ODM joint replacement manufacturer, Madison Ortho supplies orthopedic surgeons, medical device distributors, and hospital procurement departments across 40+ countries with CE Mark and ISO 13485:2016 certified hip, knee, and shoulder arthroplasty prostheses.
Engineered for optimal primary and revision hip joint reconstruction, providing high stability, reduced friction wear, and bio-anatomical alignment.
Advanced kinematically matched knee joint designs that restore original gait dynamics, ensuring natural flexion and durable mechanical fixation.
Versatile shoulder joint replacement systems designed for anatomic hemi-arthroplasty, total shoulder replacement, and complex reverse shoulder procedures.
Our implants utilize certified medical-grade alloys and polymers manufactured in accordance with strict ASTM and ISO biomedical standards.
| Component Category | Biomedical Alloy / Material | Standard Compliance | Key Clinical Advantages |
|---|---|---|---|
| Femoral & Humeral Stems | Ti-6Al-4V ELI / CoCrMo Alloy | ISO 5832-3 / ASTM F136 | High fatigue strength, low modulus of elasticity, optimal osseointegration |
| Articular Bearings & Heads | BIOLOX® Delta Ceramic / CoCrMo | ISO 6474-2 / ASTM F75 | Ultra-low wear rate, extreme scratch resistance, superior wettability |
| Acetabular & Tibial Inserts | Highly Cross-Linked Polyethylene (UHMWPE) | ISO 5834-2 / ASTM F648 | Minimized osteolysis risk, extended volumetric wear resistance |
| Surface Coatings | Porous Titanium & Hydroxyapatite (HA) | ISO 13779-2 / ASTM F1185 | Accelerated bone ingrowth, robust initial primary mechanical press-fit |
Every joint replacement implant undergoes 100% automated optical inspection, 5-axis CNC machining, ultrasonic multi-stage cleaning, and Class 10,000 cleanroom sterile packaging to meet stringent global medical device regulation (MDR).
All Madison Ortho joint replacement prostheses are certified under ISO 13485:2016 and hold official CE Mark documentation, enabling streamlined registration for global orthopedic distributors and hospital networks.
Yes. We offer complete B2B OEM manufacturing solutions, including custom implant sizing, private labeling, modified surgical instrument sets, and tailored container packaging for regional brand owners.
We execute rigorous mechanical fatigue testing, wear simulators, coordinate measuring machine (CMM) dimensional checks, and complete raw material traceability from ingot to final sterile packaging.