About Auxein Medical
Pioneering High-Precision Orthopedic Implants & Surgical Solutions for Global B2B Healthcare Partners in 75+ Countries.
Engineering Excellence for Better Surgical Outcomes
Auxein Medical is an internationally recognized medical device manufacturer specializing in the research, design, production, and global supply of orthopedic implants and surgical instruments. Guided by a relentless commitment to quality and innovation, we provide high-grade trauma, spine, sports medicine, joint prosthesis, and craniomaxillofacial solutions to hospital networks, orthopedic surgeons, and medical distributors worldwide.
Driven by the philosophy that a strong desire to make a difference is what truly sets us apart, Auxein operates state-of-the-art production facilities compliant with ISO 14644 Class 10,000 cleanroom standards. With over 20 million patients cared for globally, our generic and OEM orthopedic solutions conform to the most stringent international regulatory frameworks including US FDA 510(k), CE Mark (EU-MDR 2017/745), MDSAP, ISO 13485:2016, and Indian FDA.
US FDA 510(k) Cleared
Full regulatory clearance for bone plates, screws, intramedullary nails, spine systems, and joint prosthesis.
EU-MDR & CE Certified
Compliant with European Medical Device Regulations ensuring superior product safety and clinical efficacy.
ISO 13485 & MDSAP
Audited Quality Management System certifying high-precision manufacturing across international jurisdictions.
Class 10,000 Cleanroom
ISO 14644-compliant controlled packaging environments guaranteeing sterile barrier packaging integrity.
Why Global Procurement Leaders Trust Auxein
Combining advanced CNC multi-axis Swiss machining, rigorous mechanical testing, and clinical feedback loops to deliver reliable orthopedic hardware for demanding OR environments.
Advanced Manufacturing Plants
Equipped with modern CNC turning, milling, and laser marking technology, Auxein ensures ultra-precise tolerances on titanium and stainless steel medical alloys.
Research-Based Innovation
Our dedicated R&D engineering team collaborates closely with clinical specialists to continuously improve biomechanical design, plate contouring, and screw locking mechanisms.
OEM & Contract Manufacturing
We offer specialized original equipment manufacturing (OEM) and custom branding services for global orthopedic brands requiring reliable quality and competitive production lead times.
Guided by Industry Visionaries
Our board of directors brings decadal experience in biomechanical engineering, regulatory compliance, and global supply chain expansion to ensure long-term customer success.
Deepak Luthra
"Across every division, we combine deep manufacturing insight to make our quality systems foolproof. With an uncompromising focus on hygiene and precision, we adopt world-class standards while maintaining meticulous attention to detail."
Gaurav Luthra
"Having mastered production fundamentals from hands-on tooling to modern multi-axis CNC technology, our engineering culture blends state-of-the-art science with rigorous quality checks at every critical manufacturing stage."
Rahul Luthra
"Building upon a strong foundation of quality trauma and spine systems, we actively partner with international distributors and clinical experts to expand intuitive, cost-effective orthopedic care worldwide."
Partner with a Certified Orthopedic Manufacturer
Looking for certified trauma implants, locking plates, spinal systems, or OEM contract manufacturing? Connect with our global distribution and technical procurement experts today.