Limb Reconstruction

Leading Global Innovations in Limb Preservation, Deformity Correction, and Complex Fracture Management Systems

Comprehensive Hardware & Enabling Digital Technologies for Overseas Procurement

With over four decades of clinical innovation and ISO 13485-certified manufacturing excellence, Orthofix Limb Reconstruction Solutions delivers state-of-the-art orthopedic devices trusted by orthopedic surgeons, clinical teams, and medical distributors across more than 70 countries.

Our complete clinical portfolio addresses complex post-traumatic conditions, extremity deformity corrections, bone lengthening procedures, pediatric orthopedic challenges, and foot & ankle specialties. Backed by rigorous clinical trials, international regulatory compliance (CE Mark, FDA Clearance, EU MDR compliance), and continuous surgical training via Orthofix Academy, we empower healthcare providers to achieve optimal patient mobility and post-surgical outcomes.

ISO 13485 Certified EU MDR / CE Compliant FDA Cleared Devices OEM & Global Distribution Ready

Targeted Systems for Adult & Pediatric Care

Engineered with precision biocompatible materials to support complex reconstruction pathways and distraction osteogenesis.

Orthofix Limb Preservation System featuring TrueLok circular external fixation frame

Limb Preservation Systems

Advanced circular external fixation and soft-tissue preservation platforms engineered for salvage procedures, severe diabetic foot complications, osteomyelitis management, and non-union bone repair.

  • Modular Circular Rings
  • Radiolucent Fixation Components
  • Micrometric Strut Adjustments
  • High Biocompatibility Grade
Extremity Deformity Correction Fixator for multi-axial bone alignment and computerized frame planning

Extremity Deformity Correction

Computer-guided hexapod software paired with multi-axial external frames for multiplanar correction of congenital, developmental, and post-traumatic limb deformities in upper and lower extremities.

  • 3D Computer Planning Software
  • Multi-Planar Axis Control
  • Pediatric & Adult Sizing
  • ISO 13485 Precision Tolerance
Limb Lengthening Devices including intramedullary lengthening nails and external distraction systems

Surgical Limb Lengthening

Comprehensive lengthening technologies—combining internal motorized intramedullary nails and external distraction osteogenesis systems to treat limb length discrepancies safely and predictably.

  • Controlled Distraction Rate
  • Minimal Invasive Insertion
  • Titanium Alloy Construction
  • Extensive Clinical Validation
Complex Fracture Management fixators for polytrauma and articular trauma stabilization

Complex Fracture Management

Monolateral, hybrid, and dynamic fixators tailored for high-energy polytrauma, articular intra-op reduction, severe open fractures, and rapid emergency department damage control orthopedic surgery.

  • Quick-Clamping Ball Joints
  • Dynamic Axialization Units
  • X-Ray / MRI Compatible Materials
  • Sterile System Packaging
Advanced Biologic Solutions - IsoTis Demineralized Bone Matrix for bone graft augmentation in limb reconstruction

Integrated Biologics & Regenerative Solutions

Accelerating bone healing in complex reconstruction requires a multi-faceted biologic approach. Orthofix integrates premium IsoTis Biologics and Accell Bone Matrix technologies engineered to foster rapid osteoconduction and osteoinduction across severe bone defects, osteotomies, and non-union sites.

Developed in tissue processing centers adhering to international AATB standards, FDA registration, and rigorous quality control protocols, our biologic portfolio provides global hospital partners and surgical centers with trusted osteoinductive options for pediatric and adult cases alike.

Quality Standards & Manufacturing Specifications

Designed to meet the stringent technical, regulatory, and logistics standards required by global medical device importers, hospital tenders, and surgical distributors.

Product Line / System Material Composition Primary Clinical Indications Regulatory Clearances Packaging / Supply Format
TrueLok Circular Frame System Aluminum Alloy / Carbon Fiber / Stainless Steel Limb lengthening, severe deformity correction, tibial/femoral non-union FDA 510(k), CE Mark (EU MDR), ISO 13485 Sterile & Non-Sterile Modular Surgical Trays
LRS Monolateral Fixator High-Strength Anodized Aluminum / Titanium Pins Bone transport, lengthening, fracture stabilization, osteotomy frame FDA 510(k), CE Mark, PMDA Approved Complete Kit with Precision Instrumentation
IsoTis Demineralized Bone Matrix Demineralized Human Allograft / Reverse Phase Medium Segmental defect filling, osteotomy graft enhancement, arthrodesis FDA 21 CFR Part 1271, ISO 13485, AATB Accredited Pre-filled Syringes (1cc, 2.5cc, 5cc, 10cc)
Pediatric Deformity & Trauma Fixation Lightweight Carbon Fiber & Biocompatible Alloy Congenital limb dysplasia, pediatric physeal fractures, Blount's disease FDA 510(k), CE Mark (EU MDR) Color-Coded Pediatric Instrument Trays

Partner with a Global Medical Device Pioneer

Looking for reliable OEM partnership, international distribution distribution rights, or hospital tender quotes? Our international regulatory and procurement team is ready to support your market needs.