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SmartBone®:
Advanced bone regeneration for orthopaedic excellence
SmartBone® is an innovative bone substitute designed to revolutionise reconstructive surgeries. Developed by Industrie Biomediche Insubri SA (IBI), SmartBone® combines cutting-edge materials and biocompatible properties to provide unmatched strength, stability, and regeneration.
Applications
Hand
RegJoint™ is suitable for arthroplasty of small joints in the hand, including:
Carpometacarpal (CMC) Joints: Particularly effective in the CMC I joint, commonly affected by osteoarthritis.
Metacarpophalangeal (MCP) Joints: Applicable for MCP II-V joints, often impacted by rheumatoid arthritis.
Foot
In the foot, RegJoint™ addresses small joint issues such as:
Metatarsophalangeal (MTP) Joints: Effective for MTP I-V joints, providing relief in conditions like hallux rigidus
and other degenerative joint diseases.
Bone regeneration
SmartBone® ORTHO is a cutting-edge bone substitute engineered for effective bone regeneration in orthopaedic and spine surgeries.
This hybrid bioactive material combines natural mineral bone structures with bio-resorbable polymers and collagen fragments, promoting rapid and efficient integration with the patient's own bone. Its unique microstructure, featuring optimal porosity, ensures robust osteoconductivity, biocompatibility, and biodegradability, making it suitable for various reconstructive procedures.
Enhanced Surgical Handling
Allows for precise, dust-free shaping with standard surgical tools, facilitating tailored implantation.
Structural Integrity
Offers exceptional resistance to heavy loads and surgical manipulation, ensuring stability post-implantation.
Reduced Morbidity
Eliminates the need for autologous bone harvesting in larger defects, minimizing patient discomfort and recovery time.
Stable Integration
The polymeric coating safeguards the graft during the initial healing phase, preventing premature resorption and enhancing osteointegration.
Efficient Hemostasis
Readily absorbs blood, supporting natural clot formation and accelerating the healing process.
Applications of SmartBone®
SmartBone® ORTHO is an ideal solution for trauma and reconstructive bone surgeries, offering superior stability, biocompatibility, and osteointegration. Designed to meet the demands of orthopaedic trauma cases, it is particularly effective for treating bone defects caused by fractures, resections, or congenital abnormalities.
In trauma surgery, SmartBone® ORTHO provides an immediate structural framework that withstands physiological loads while promoting new bone growth. Its unique hybrid composition allows for natural bone remodeling, ensuring long-term integration and durability. The material can be shaped precisely with standard surgical tools, enabling a customised fit for complex reconstructive cases.For revision surgeries, where bone loss or implant loosening is a concern, SmartBone® ORTHO facilitates osteointegration by offering a strong yet bio-resorbable scaffold. Its composite structure mimics natural bone, allowing for enhanced mechanical resistance and reducing the risk of implant failure. The polymeric coating helps maintain stability during the early healing phase while supporting gradual bone remodelling.
SmartBone® ORTHO is a highly effective bone substitute for primary arthroplasty and complex revision surgeries, providing structural support and promoting long-term bone regeneration. In joint replacement procedures, it serves as an optimal grafting material for bone defects, ensuring stability and enhancing implant fixation.
SmartBone® ORTHO is an ideal bone graft solution for paediatric orthopaedic applications, offering a safe, biocompatible, and adaptable material for young, growing patients. Unlike traditional bone substitutes, SmartBone® ORTHO provides a balance of structural support and bio-resorbability, allowing for natural bone remodelling without interfering with skeletal development.
In paediatric trauma, congenital deformities, or corrective procedures, SmartBone® ORTHO supports effective bone healing while minimising surgical intervention. Its mechanical properties enable easy shaping to fit specific anatomical needs, making it particularly useful in limb reconstruction, fracture management, and spinal corrections.
Technical Specifications
SmartBone® ORTHO is a CE-marked Class III medical device compliant with the 93/42/EEC Medical Device Directive. Its composite structure mirrors human bone's open and interconnected porosity, facilitating rapid cellular colonization and vascularization.
The material is available in various shapes, including blocks, wedges, rods, and granules, allowing for versatile application across different surgical scenarios. Its mechanical properties enable easy, dust-free shaping with standard surgical instruments, and its resilience ensures stability under substantial physiological loads.
FAQs – SmartBone®
No. SmartBone® is not compatible with PMMA or other exothermic cements. The heat generated during polymerisation can compromise the integrity of the composite structure. SmartBone® is designed for biological fixation, not cemented applications.
Yes. SmartBone® provides immediate mechanical stability and is suitable for segmental defects. It maintains structural integrity under load while promoting natural bone ingrowth and remodelling.
Absolutely. SmartBone® can be cut, drilled, and fixed using standard surgical tools. It handles well in theatre and resists fragmentation during preparation and implantation.
Yes. Sovereign Medical offers 3D-printed SmartBone® grafts based on CT data, tailored to complex oncologic defects. Custom solutions reduce OR time and improve anatomical fit.
SmartBone® remodels gradually over 6–18 months (maintaining mechanical strength), depending on defect size and biological environment. Its composite structure supports early vascularisation and cellular colonisation.
Sovereign Medical provides full support, including surgical planning, product selection, and coordination of custom 3D grafts. We work closely with oncology centres across the UK to support case-specific needs.
Clinical Evidence
Clinical investigations have validated the efficacy of SmartBone® ORTHO in bone regeneration. The material's design allows it to absorb significant amounts of blood, initiating micro-coagulation within the graft. This process enhances graft integration by promoting native cell ingrowth.
Over the initial weeks, cellular colonization is facilitated by the presence of gelatin, providing a conducive environment for cell proliferation. As the bioresorbable polymers degrade, they leave behind a mineral structure that supports new bone formation and vascularization. Complete integration with the patient's native bone typically occurs within one to two years, resulting in vital, functional bone-implant integration.
These studies underscore SmartBone® ORTHO's role as a safe and effective material for bone regeneration in orthopaedic applications.