Pioneering Orthopedic Excellence Since 1996
Auxein Medical began its journey in 1996 under the vision of Mr. Ashok Luthra, starting as Crown Plastic in Delhi NCR to address the regional deficit in reliable, high-precision hip prosthetics like the Austin Moore system. What started as a dedicated engineering unit quickly gained recognition among senior orthopedic surgeons for its impeccable quality and exacting manufacturing finish.
By 1999, the founder was joined by his elder sons, Deepak and Gaurav Luthra, who integrated modern production technologies and business management systems, expanding the product offering to comprehensive trauma fixation systems and establishing state-of-the-art facilities in Kundli Industrial Area.
In 2008, Rahul Luthra returned from advanced studies in Australia and New Zealand, initiating an aggressive era of global compliance, automated CNC precision manufacturing, and international export expansion. Rebranded as Auxein Medical, the organization established world-class cleanrooms, advanced mechanical testing facilities, and international distribution hubs across the USA, Mexico, Dubai, and Europe.
"Our openness to innovation and strict adherence to global regulatory standards make us a trusted partner for surgeons worldwide. Every implant we manufacture reflects our commitment to patient safety, surgical precision, and long-lasting partnership."
Key Milestones in Our Global Journey
A timeline of technological breakthroughs, international quality certifications, and expansion across global healthcare markets.
Foundation of Crown Plastic
Established Delhi NCR's first production unit dedicated to manufacturing Austin Moore hip prostheses, meeting high standards of local surgical demand.
Bone Plate & Screw Division
Expanded manufacturing capabilities into trauma care with a dedicated production line for standard bone plates and fixation screws.
Intramedullary Nailing Launch
Introduced Universal Tibia and Femur Intramedullary Nailing Systems, supporting complex long-bone fracture repairs.
Kundli Facility & CMF Line
Constructed a modernized production plant in Kundli Industrial Area and launched a dedicated Cranio-Maxillofacial (CMF) implant range.
Automated Machining Integration
Pioneered high-precision CNC Vertical Machining Centers (VMC) imported from HAAS (USA) to enhance dimensional accuracy.
Rebrand to Auxein Medical & CE Approval
Rebranded as Auxein Medical with a WHO-GMP compliant facility. Secured CE mark, ISO 9001:2008, and ISO 13485:2003 certifications, securing initial export distributors in Algeria and Colombia.
Arab Health Debut & Market Growth
Exhibited internationally at Arab Health Dubai; signed exclusive distribution partnerships across Sri Lanka, UAE, and Romania.
European OEM Contracts & Indian FDA
Awarded OEM manufacturing contracts for leading medical device partners in France, Germany, and Spain. Received official Indian FDA approval.
Swiss Lathe Swiss-Type Precision & AAOS
Installed STAR (Japan) CNC sliding head machines for bone screw turning; debuted at the American Academy of Orthopaedic Surgeons (AAOS) in the USA.
US FDA 510(k) Clearance
Achieved landmark US FDA 510(k) clearance for orthopedic locking plates and screws, opening direct access to the North American market.
Cleanroom & 3D Patient-Specific Implants
Constructed an ISO 14644-1 certified Cleanroom and Microbiology Lab; achieved BSI ISO 13485:2016 for 3D-printed Patient-Specific Implants (PSI).
VIBRONICS Testing Lab & MDSAP
Established the "VIBRONICS" mechanical testing laboratory equipped with Instron machines; became India's first orthopedic manufacturer to earn MDSAP Certification.
Asia's First EU-MDR 2017/745 Certification
Expanded into Sports Medicine and Variable Angle Plating; became Asia’s first orthopedic enterprise to earn EU-MDR 2017/745 Certification for Trauma Plating, Screws, and Nailing Systems.
Engineered for Safety, Quality & Compliance
Our state-of-the-art infrastructure and rigorous quality control protocols provide complete reliability for orthopedic distributors and hospital networks worldwide.
In-House Biomechanical Testing
Equipped with advanced Instron testing rigs in our VIBRONICS lab to validate fatigue strength, torsional rigidity, and stress distribution according to ASTM & ISO standards.
Japanese & German CNC Machining
Utilizing high-speed Star, Citizen, Mazak, and Haas CNC multi-axis machines for sub-micron precision manufacturing of titanium and stainless steel implants.
Tier-1 Regulatory Compliance
Backed by US FDA 510(k), EU-MDR 2017/745, MDSAP, ISO 13485:2016, and Indian FDA certifications ensuring seamless global customs clearance and market access.
Global Logistics & OEM Support
Operating direct regional hubs in the USA, Mexico, UAE, and Spain to deliver responsive supply chain logistics, custom branding, and technical surgeon support.
Partner with a Certified Global Orthopedic Manufacturer
Whether you are seeking high-quality trauma implants, contract OEM manufacturing, or territorial distribution partnerships, Auxein Medical provides fully compliant, surgeon-approved solutions tailored to your market requirements.
Contact Us