Medisplint
Medisplint
Direct factory-to-hospital trauma solutions optimized for precision osseointegration and stable mechanical fixation.
The healthcare system in France, coordinated under the authority of the **ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)** and validated by **HAS (Haute Autorité de Santé)**, commands some of the most rigorous orthopedic standards globally. French hospitals (both public *CHUs* and private clinic networks like *Ramsay Santé*) demand extreme biomechanical reliability, compliance, and material cleanliness in their internal fixation technologies.
With the transition to the **EU Medical Device Regulation (MDR 2017/745)**, the registration process has shifted focus toward robust clinical evidence, proactive post-market surveillance, and comprehensive biocompatibility logs. Traditional suppliers are undergoing significant scrutiny, resulting in supply gaps. This is where Medisplint's compliant production pathways step in, bridging high-end trauma screw requirements with efficient global logistics.
Our specialized cannulated compression screws provide local French surgeons with optimal tools for stable scaphoid, femoral neck, and ankle fractures. By ensuring a perfect fit through self-drilling and self-tapping designs, we significantly reduce operating room duration and optimize patient outcomes.
Pioneering the next era of bio-absorbable and smart orthopedics for European clinics.
Transitioning from traditional titanium to magnesium-based alloys. These alloys slowly dissolve after bone consolidation, eliminating the need for a secondary implant removal surgery—a massive cost-saving feature for France's L'Assurance Maladie.
Developing electrochemical anodization and SLA (Sandblasted, Large-grit, Acid-etched) surfaces on cannulated titanium screws. These boost cell growth, leading to faster bone healing and higher mechanical stability under fatigue stress.
Full integration with EUDAMED requirements via micro-laser etched Unique Device Identification (UDI) codes on screw heads. This guarantees complete tracking from our precision CNC lathes to the surgical ward.
Engineered with fine-pitch surgical threads to generate strong bone fragment compression.
A look inside our 18,500㎡ facility, where precision engineering meets rigorous Quality Assurance.
Our heavy CNC setup ensures micron-level tolerances for orthopedic threads.
Where mechanical verification ensures patient safety. Zero failure rate tolerance.
Full portfolio of titanium alloy bone compression screws built to CE and international regulatory benchmarks.
Streamlining procurement pipelines and clearing high-level logistics parameters within the European Economic Area.
We prepare clean biological evaluation reports (ISO 10993 series) and mechanical test records (ASTM F543 parameters) to facilitate seamless regulatory evaluation by French authorities.
Flexible delivery terms (FOB, CIF, DDP) supporting local French distributors and logistics coordinators in bidding for municipal and departmental clinical supply networks.
Customized peelable double-pouches under sterile conditions. Custom graphic labeling supporting French labeling requirements, including warning and usage data in French.
Resolving critical compliance, logistical, and technical queries regarding orthopedic device imports.
