Auxein Medical: Orthopaedic Implants, Trauma Devices and Surgical Instruments

Auxein Medical is an Indian medical-device manufacturer specializing in orthopaedic implants, trauma systems, surgical instruments, sports-medicine products and related medical technologies. The company has developed from a small Indian orthopaedic manufacturing business into an international medical-device organization serving customers and healthcare professionals across more than 75 countries.

Its product portfolio covers a wide range of orthopaedic applications, including trauma plating, screws, intramedullary nailing, hip replacement, spine implants, craniomaxillofacial systems, sports medicine, hand and foot systems, pelvic implants, surgical instruments and power tools.

Auxein’s current website reports 3,000+ products, 500+ employees worldwide, 150+ global distributors and operations reaching 75+ countries.

Auxein Medical Company Overview

Particular Details Company Auxein Medical Industry Medical Devices / Orthopaedics Main business Orthopaedic implants and instruments Major specialties Trauma, spine, hip, sports medicine, CMF, foot & ankle, hand & wrist Original business established 1996 Auxein Medical current identity Developed from the Crown Plastic business and modernized from 2008 onward Founder Ashok Luthra Chairman Deepak Luthra Global Manufacturing / Regulatory leadership Gaurav Luthra Global Sales & Marketing Rahul Luthra Main Indian facility Kundli Industrial Area, Sonipat, Haryana Products 3,000+ Countries reached 75+ Global distributors 150+ Employees 500+ worldwide Major certifications US FDA 510(k), CE, MDSAP, ISO 13485:2016, EU MDR Indian regulatory status Indian FDA approved / GMP International offices USA, Mexico, Dubai and Spain, in addition to India

The company’s current official website lists its Indian headquarters/manufacturing location at Kundli Industrial Area, Sonipat, Haryana.

Who Founded Auxein Medical?

The roots of Auxein Medical go back to Mr. Ashok Luthra.

According to the company’s official history, Ashok Luthra started with a small engineering-equipment manufacturing unit. His entry into orthopaedic implants came after a surgeon friend recognized the quality and finish of his products.

In 1996, the predecessor company Crown Plastic was established to manufacture the Austin Moore Prosthesis. Auxein describes this as Delhi’s first production unit in this category.

This early focus on hip prostheses eventually expanded into trauma implants, bone plates, screws, nails and other orthopaedic products.

The Luthra family subsequently became deeply involved in the company’s expansion.

Key Family Leadership

Ashok Luthra – Founder

He established the business that became the foundation of Auxein Medical and is identified by the company as its founder.

Deepak Luthra – President & Chairman of the Board

Deepak joined the business in 1999 and became involved in management and organizational development. Auxein currently identifies him as President and Chairman of the Board.

Gaurav Luthra – Vice President, Global Manufacturing & Regulatory Head

Gaurav is responsible for important areas involving manufacturing and regulatory operations.

Rahul Luthra – Vice President, Global Sales & Marketing

Rahul joined the business after higher studies in Australia and New Zealand and helped drive international expansion and modernization.

When Was Auxein Medical Established?

There are two dates that are important when describing Auxein’s history.

1996 – Beginning of the Orthopaedic Manufacturing Business

The predecessor company, Crown Plastic, was established in 1996 to manufacture the Austin Moore Prosthesis.

2008–2009 – Birth of Modern Auxein Medical

The company says that in 2008, Rahul Luthra’s return and the push toward modernization and international expansion marked the transformation that led to Auxein Medical in its current form.

The company’s history records 2009 as the point when Crown Plastic was reborn as Auxein Medical and a new WHO-GMP-compliant manufacturing unit commenced exports. CE and ISO certifications were also obtained during this phase.

Therefore, a website article should not simply state that Auxein started in 2008 or 2009 without explaining the earlier 1996 history.

What Does Auxein Medical Manufacture?

Auxein manufactures a large range of orthopaedic medical devices.

Its current product categories include:

  • Trauma implants
  • Locking plates
  • Bone screws
  • Cannulated screws
  • Intramedullary nails
  • Hip prostheses
  • Spine implants
  • Pelvic plating systems
  • Pediatric orthopaedic systems
  • Craniomaxillofacial implants
  • Sports-medicine implants
  • Hand and wrist systems
  • Foot and ankle systems
  • Shoulder systems
  • Knee and elbow products
  • Surgical power tools
  • Orthopaedic instruments

The company currently reports 3,000+ products across its portfolio.

Main Auxein Medical Product Categories

1. Trauma Implants

Trauma is one of Auxein’s major areas.

Its trauma portfolio includes systems designed for fracture fixation and reconstruction.

The company lists:

  • Mini-fragment systems
  • Small-fragment systems
  • Large-fragment systems
  • Staples
  • Pins
  • Wires
  • Trauma plates
  • Screws
  • Locking systems

Auxein describes its traumatology portfolio as a broad range of orthopaedic implants.

These products are used by orthopaedic surgeons for the stabilization and fixation of fractured bones.

2. Wise-Lock Locking Plate Systems

Locking plate technology is an important part of modern fracture fixation.

Auxein offers its Wise-Lock family of locking plate systems.

Locking plates use specially designed screw-plate interfaces that can provide angular stability between the screw and plate.

They are used in different anatomical regions depending on the specific implant system.

3. Cannulated Screw Systems

Cannulated screws have a hollow central channel that allows them to be guided over a guidewire during surgery.

Auxein offers cannulated screw systems for orthopaedic applications.

These systems are particularly useful in procedures where accurate screw positioning is important.

4. Intramedullary Nailing Systems

Auxein also manufactures nailing systems.

Intramedullary nails are inserted inside the medullary canal of a long bone and are commonly used for fracture stabilization.

The company has a history of developing tibial and femoral nail systems, with its timeline recording the addition of a Universal Tibia & Femur Nails division in 2003.

5. Hip Prostheses

Hip replacement has been part of the company’s history since its early Austin Moore Prosthesis manufacturing.

The company now offers hip prosthesis products as part of its broader orthopaedic portfolio.

Hip replacement implants may include components designed to replace damaged portions of the hip joint.

6. Spine Implants

Auxein’s portfolio also includes spinal implant systems.

The company’s current product information includes spine as one of its major product categories, and its certification portfolio includes US FDA 510(k) clearances for relevant systems.

7. Pelvic Plating Systems

Pelvic fractures can require complex fixation because of the anatomy and load-bearing function of the pelvis.

Auxein offers pelvic plating systems as part of its trauma and reconstruction portfolio.

8. Pediatric Orthopaedic Systems

Auxein also has a pediatric system designed for orthopaedic applications involving younger patients.

Pediatric orthopaedic implants require different sizing and design considerations because children’s bones are still developing.

9. Craniomaxillofacial Implants

Auxein has a dedicated CMF – Cranio-Maxillofacial System.

The company entered cranio-maxillofacial implants during its earlier expansion and later developed customized patient-specific implant capabilities.

In 2017, the company records the addition of a patient-specific implant category and an India’s-first 3D-printed customized maxillofacial implant claim.

10. Sports Medicine

Sports medicine has become an important expansion area for Auxein.

The company’s current portfolio includes sports-medicine products and its timeline records the introduction of a sports-medicine line in 2022.

Applications can include procedures involving:

  • Ligaments
  • Tendons
  • Arthroscopy
  • Joint stabilization
  • Soft-tissue fixation

11. Hand and Wrist Systems

Auxein’s current product portfolio includes dedicated Hand & Wrist systems.

These systems are designed for orthopaedic procedures involving the small bones and joints of the hand and wrist.

12. Foot and Ankle

The company also lists Foot & Ankle as a dedicated category.

This includes implant solutions intended for fracture fixation and reconstruction involving the foot and ankle.

13. Shoulder

Shoulder products are another category listed by Auxein.

The company has expanded its portfolio beyond traditional trauma products toward a broader joint and sports-medicine offering.

14. Knee and Elbow

Auxein also lists Knee & Elbow among its current orthopaedic categories.

15. Surgical Instruments and Power Tools

Auxein is not limited to implants.

Its portfolio also includes power tools and surgical instruments used during orthopaedic procedures.

This is important because implant surgery generally requires an accompanying instrumentation ecosystem.

The company’s current product list includes Power Tools alongside implants such as plates, screws and nails.

How Many Products Does Auxein Medical Have?

Auxein currently states that it has more than 3,000 products available.

This figure is considerably broader than simply counting major product families.

The portfolio includes individual implant sizes, configurations, instruments, fixation components and systems.

Therefore, the most accurate website statement is:

Auxein Medical offers more than 3,000 products across its orthopaedic implant and medical-device portfolio.

This figure comes directly from the company’s current website.

Manufacturing Facilities

Manufacturing has always been a major part of Auxein’s development.

The company currently identifies its principal Indian facility at:

Kundli Industrial Area, Sonipat, Haryana

Its history shows a gradual expansion of manufacturing capabilities.

Manufacturing Timeline

1996:
Initial Austin Moore Prosthesis manufacturing.

2006:
A modern manufacturing unit was established at Kundli Industrial Area.

2009:
A new WHO-GMP-compliant manufacturing unit was introduced as Auxein entered export markets.

2012:
Manufacturing capabilities were expanded with a second unit.

2015:
A third manufacturing unit was added.

2021:
Expansion of Unit 2 and additional machinery.

These milestones demonstrate that the company evolved from a relatively small implant manufacturer into a larger integrated manufacturing organization.

Advanced Manufacturing Technology

Auxein has progressively introduced advanced manufacturing equipment.

Its history mentions equipment from international manufacturers including:

  • HAAS
  • Mazak
  • OTEC
  • STAR
  • Citizen
  • Stratasys

The company also added automated CNC machinery, precision sliding-head machines and specialized surface-finishing technology.

In 2019, Auxein established a mechanical testing laboratory under the VIBRONICS name, with testing equipment from companies including Instron.

3D Printing and Patient-Specific Implants

One of the more technologically advanced areas in Auxein’s history is patient-specific manufacturing.

The company added a patient-specific implant category and reported development of customized 3D-printed maxillofacial implants.

This technology can be important when standard implants are not ideal for a patient’s anatomy.

Instead of using only off-the-shelf geometry, patient-specific implants can be designed around individual anatomical requirements.

Clean Room and Quality-Control Infrastructure

Auxein’s manufacturing ecosystem includes an ISO 14644-compliant Class 10,000 clean-room facility.

The company also reports a microbiology laboratory and mechanical testing capabilities.

These facilities support manufacturing and testing requirements for medical implants.

International Certifications

Auxein has developed an extensive regulatory and certification portfolio.

Its current website lists:

  • US FDA 510(k) clearances
  • CE marking
  • MDSAP
  • ISO 13485:2016
  • EU MDR 2017 certification
  • Indian FDA approval
  • GMP certification

Its certification page also lists specific US FDA 510(k) clearances covering systems such as plates and screws, tibia/fibula systems, humerus/ulna systems, Vertaux pedicle screw systems and PEEK Optima screw-in suture anchors.

US FDA 510(k) Clearances

FDA 510(k) clearance is particularly important for companies entering the United States medical-device market.

Auxein reports US FDA 510(k) clearances for several product categories, including:

  • Bone plates and screws
  • Humerus and ulna systems
  • Tibia and fibula systems
  • Pedicle screw systems
  • PEEK suture anchors

These clearances demonstrate the company’s effort to meet regulatory requirements in the US market.

Global Market Presence

Auxein currently reports:

  • 75+ countries reached
  • 150+ global distributors
  • 500+ worldwide employees
  • 3,000+ products
  • 20 million+ patients cared for

These figures are company-reported and can change over time.

The company has established international offices or entities in:

  • United States
  • Mexico
  • Dubai
  • Spain

in addition to its Indian operations.

Where Does Auxein Sell Its Products?

Auxein has developed distribution relationships across multiple international regions.

Its history records early distribution agreements in:

  • Algeria
  • Colombia
  • Sri Lanka
  • United Arab Emirates
  • Romania

The company subsequently expanded into additional international markets.

Its current reported reach of 75+ countries demonstrates that Auxein’s products are no longer limited to the Indian market.

Auxein Medical’s International Expansion

The company’s international expansion accelerated after the late 2000s.

Important milestones include:

2009: First distribution agreement in Africa.

2009: First Latin American distribution agreement.

2010: International exhibition participation at Arab Health.

2010: Distribution relationships in Asia-Pacific, Middle East and Europe.

2011: OEM contracts involving France, Germany and Spain.

2013: Participation at the AAOS conference in the United States.

These milestones helped move Auxein from a domestic manufacturer toward a global orthopaedic-device business.

Auxein’s OEM Business

Auxein also works in the OEM segment.

OEM manufacturing means that a medical-device company can manufacture products or components for another company, potentially under the customer’s brand or specifications, depending on the commercial and regulatory arrangement.

Auxein says that its product quality and manufacturing capabilities have enabled it to provide OEM services to leading names in the industry.

Research and Development

Research and development is an important part of Auxein’s current strategy.

The company describes itself as an integrated, research-based orthopaedic implant and instrument manufacturer.

Its R&D interests include:

  • Implant design
  • Product customization
  • Patient-specific implants
  • New fixation systems
  • Sports medicine
  • Orthopaedic instrumentation
  • Manufacturing-process improvements
  • Regulatory compliance
  • Mechanical testing

The company states that it is increasing its focus on R&D, innovation and customization.

Latest Developments in 2026

Auxein’s current 2026 activity shows continued expansion of its orthopedic education and international presence rather than a single newly announced flagship implant replacing its existing portfolio.

One recent 2026 development is Auxein Advance, which conducted a sports-medicine cadaveric course in Germany in July 2026. The program focused on hands-on sports-medicine training and demonstrates the company’s increasing emphasis on surgeon education and international clinical engagement.

The company is also participating in international medical events during 2026, including planned appearances at:

  • SECOT 2026 in Spain
  • FEMECOT 2026 in Mexico
  • MEDICA Düsseldorf 2026 in Germany

This indicates continued expansion of its global orthopaedic business and professional-education activities.

Important 2024 Regulatory Milestone

Auxein’s history records another major milestone in 2024: the company became Asia’s first to obtain EU MDR 2017/745 certification for Trauma Plating, Screws and Nailing Systems, according to its own published history. The company also lists US FDA 510(k), CE, MDSAP, ISO 13485:2016 and EU MDR certifications.

What Makes Auxein Medical Different?

Auxein’s business model combines several elements rather than concentrating on only one implant category.

Integrated Manufacturing

The company controls multiple stages of product development and manufacturing.

Large Product Portfolio

With 3,000+ products, Auxein can serve a broad range of orthopaedic procedures.

Trauma Expertise

Trauma fixation remains one of its historical strengths.

International Regulatory Capability

US FDA, CE, MDSAP and EU MDR credentials support international market access.

Customization

The company has invested in patient-specific implants and 3D-printing capabilities.

Surgeon Education

Programs such as Auxein Advance demonstrate an increasing focus on training and education.

Auxein Medical Product Categories at a Glance

Category Examples / Applications Trauma Plates, screws, pins, wires, staples Locking Systems Wise-Lock plates and fixation systems Nailing Tibia, femur and other intramedullary systems Hip Hip prostheses Spine Spinal fixation systems Pelvis Pelvic plating CMF Cranio-maxillofacial implants Sports Medicine Sports and soft-tissue procedures Hand & Wrist Small-joint and fracture fixation Foot & Ankle Foot and ankle reconstruction Shoulder Shoulder orthopaedic products Knee & Elbow Joint and fixation systems Pediatric Pediatric orthopaedic systems Instruments Orthopaedic surgical instruments Power Tools Surgical power-tool systems

Frequently Asked Questions

When was Auxein Medical founded?

The roots of the company go back to 1996, when Crown Plastic was established to manufacture the Austin Moore Prosthesis. The modern Auxein Medical identity developed during the 2008–2009 transformation and international expansion period.

Who is the founder of Auxein Medical?

Mr. Ashok Luthra is identified by Auxein as its founder.

Who runs Auxein Medical?

The company’s current leadership includes Deepak Luthra, President & Chairman of the Board; Gaurav Luthra, Vice President for Global Manufacturing and Regulatory; and Rahul Luthra, Vice President for Global Sales & Marketing.

What does Auxein Medical manufacture?

Auxein manufactures orthopaedic implants, trauma systems, plates, screws, nails, hip prostheses, spine products, pelvic systems, CMF implants, sports-medicine products, surgical instruments and power tools.

How many products does Auxein have?

Auxein currently reports more than 3,000 products.

How many countries does Auxein Medical serve?

The company currently reports reaching more than 75 countries through its global business and distribution network.

Does Auxein have US FDA approval?

Auxein has multiple US FDA 510(k) clearances for specific medical-device systems. These include certain plate and screw systems, tibia/fibula systems, humerus/ulna systems, pedicle screw systems and suture anchors.

Is Auxein Medical an Indian company?

Yes. Auxein’s main manufacturing operation is located in Kundli Industrial Area, Sonipat, Haryana, India, while the company maintains international operations and offices.

Does Auxein manufacture surgical instruments?

Yes. Its portfolio includes surgical instruments and power tools in addition to orthopaedic implants.

Does Auxein manufacture sports-medicine products?

Yes. Sports medicine is one of Auxein’s current product categories, and the company records the introduction of its sports-medicine line in 2022.

What is Auxein’s latest development?

In 2026, Auxein has continued expanding international surgeon education and sports-medicine activities. Its Auxein Advance program conducted a sports-medicine cadaveric course in Germany in July 2026. The company is also scheduled to participate in several international orthopaedic events during 2026.

Conclusion

Auxein Medical has evolved from a small Indian orthopaedic manufacturing operation into a global medical-device company with a reported 3,000+ product portfolio and presence in more than 75 countries.

The company’s roots go back to 1996, when founder Ashok Luthra established Crown Plastic to manufacture the Austin Moore Prosthesis. Over the following decades, the business expanded into trauma implants, plates, screws, nails, hip prostheses, spine systems, CMF implants, sports medicine, surgical instruments and power tools.

Today, Auxein combines implant manufacturing, engineering, R&D, patient-specific technologies, mechanical testing and international regulatory capabilities. Its certifications and regulatory clearances include US FDA 510(k), CE, MDSAP, ISO 13485:2016 and EU MDR, while its Indian operations hold relevant Indian regulatory approvals and GMP credentials.

With continued investment in sports medicine, customized implants, surgeon education and international expansion, Auxein Medical is positioning itself as one of India’s significant indigenous manufacturers of orthopaedic implants and surgical technologies.

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