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Global certified musculoskeletal portfolio engineered for spinal reconstruction, surgical navigation, limb preservation, and non-invasive therapeutic recovery.

Medical Technology & Manufacturing Excellence

Advancing Global Musculoskeletal Healthcare & Surgical Precision

Orthofix is a globally recognized medical device manufacturer dedicated to engineering precision-guided surgical implants, advanced biologies, and therapeutic recovery systems. Supporting hospitals, orthopedic surgeons, and international healthcare distributors across 70+ countries, our solutions comply with rigorous FDA, CE Mark, and ISO 13485 quality standards to drive superior clinical fusion rates and patient mobility outcomes.

ISO 13485 Certified Manufacturing Quality
FDA Cleared Full Regulatory Compliance
CE Marked Global Distribution Approved
500+ Studies Peer-Reviewed Clinical Data

Comprehensive Product Portfolio

Five Specialized Medical Divisions

Orthofix spinal surgical implants for cervical, lumbar, and thoracolumbar fusion
Division 01

Spinal Solutions

Engineering high-performance interbody fusion cages, pedicle screw fixation systems, and structural reconstruction devices. Engineered to treat degenerative disc disease, spinal deformity, trauma, and tumor cases, featuring proprietary WaveForm® 3D-printed titanium and NanoMetalene® molecular surface technologies.

Core Applications Cervical, Thoracolumbar & Sacroiliac
Surface Tech NanoMetalene® & WaveForm® 3D
Surgical Modality MIS, Open & Lateral Fusion
Quality Standard FDA Cleared / CE Compliant
7D FLASH surgical navigation system utilizing machine-vision technology for spine and cranial navigation
Division 02

Surgical Navigation Solutions

The 7D FLASH™ Navigation System leverages proprietary optical machine-vision technology and spatial algorithms to eliminate intraoperative radiation. Designed for fast intraoperative scanning, achieving registration in under 30 seconds to elevate surgical precision and streamline operating room throughput.

Technology Machine-Vision Optical Guidance
Radiation Safety Zero Radiation Exposure
Registration Speed < 30 Seconds Auto-Registration
Procedure Focus Spinal & Cranial Interventions
Orthofix TrueLok limb reconstruction hardware and deformity correction external fixators
Division 03

Limb Reconstruction Solutions

A worldwide industry standard in pediatric and adult extremity deformity correction, limb lengthening, and complex trauma fixators. Featuring TrueLok™ ring fixators and digital planning software to manage complex non-unions, osteomyelitis, and limb preservation pathways.

Clinical Scope Deformity, Trauma & Lengthening
Hardware Systems Circular & Monolateral Fixators
Patient Segment Adult & Pediatric Orthopedics
Digital Support Software-Assisted Frame Alignment
Orthofix non-invasive bone growth therapy devices and bracing solutions
Division 04

Therapeutic Solutions

Non-invasive post-surgical bone growth stimulators powered by clinically validated Pulsed Electromagnetic Field (PEMF) technology. SpinalStim™ and CervicalStim™ deliver uniform electromagnetic signaling to stimulate bone healing cascades and enhance fusion success in high-risk non-union patients.

Mechanism Pulsed Electromagnetic Field (PEMF)
Proven Efficacy High Success in Non-Union Healing
Device Range Spinal, Cervical & Extremity Stimulators
Patient Care Lightweight & Ergonomic Compliance
Orthofix IsoTis bone graft substitutes, DBM, and cellular allografts for orthopedic surgery
Division 05

Biologics Solutions

Advanced osteoinductive Demineralized Bone Matrices (DBM), synthetic bone graft substitutes, and cellular allografts. Formulated under strict tissue banking standards in partnership with MTF Biologics® to accelerate bone remodeling and graft integration across orthopedic and spinal procedures.

Product Portfolio Accell® DBM, IsoTis® & Allografts
Biological Activity Osteoinductive & Osteoconductive
Processing Processed in AATB Accredited Facilities
Handling Formats Putty, Fibers, Pastes & Injectables

International Trade & Quality Standards

Export Compliance & Global OEM/Distribution Support

Regulatory & Quality Certification

  • ISO 13485 Certified Medical Quality Management System
  • FDA Cleared Medical Devices & 510(k) Master Files
  • CE Mark Certified for European Union Distribution
  • Full Traceability & Sterilization Validation Protocols

Supply Chain & Logistics

  • Cold-chain biologies shipment capabilities worldwide
  • Streamlined export documentation & Certificate of Free Sale
  • Dedicated B2B procurement support for hospital tenders
  • Flexible bulk supply packaging for international importers

Surgeon Education & Clinical Backing

  • Over 500 peer-reviewed clinical studies & trials
  • Comprehensive surgical technique guides & IFU documents
  • Hands-on training via the Orthofix Academy framework
  • 24/7 technical specialist consultation for OR teams

Partner with a Trusted Global Medical Device Manufacturer

Whether you are an international medical device distributor, hospital procurement director, or orthopedic surgical team, Orthofix delivers certified solutions tailored to your operational needs.

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