Medisplint
Medisplint
CE-Certified trauma plates and screws optimized for complex anatomical geometries and high-stability internal fixation.
Addressing the strict clinical guidelines set forth by the Norwegian Regional Health Authorities (Helseforetak) and CE MDR.
The Norwegian healthcare model, coordinated by the centralized purchasing organization Sykehusinnkjøp HF, demands the highest standards of biosafety, documentation, and tracebility for surgical implants. Trauma surgeries across Norwegian hospitals, particularly in major regional centers like Oslo University Hospital (OUS), Haukeland University Hospital, and St. Olavs Hospital, require osteosynthesis implants that offer anatomical pre-contouring to reduce operating room times and minimize soft-tissue irritation.
Due to Norway’s active demographics and winter climate, there is a high incidence of fracture patterns related to sports trauma (e.g., ski and snowboarding alpine accidents) and geriatric fragility falls. Distal radius, clavicle, and tibial fractures dominate the clinical intake. Implants must utilize medical-grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3 standards to ensure optimal biocompatibility, mechanical fatigue limit, and compatible MRI scanning properties. Furthermore, compliance with EU MDR 2017/745 is non-negotiable for all manufacturers supplying this region.
Ensuring full alignment with Norway's national procurement system, supporting tender specifications with comprehensive clinical evaluation reports (CER) and EUDAMED registration.
Designed to match typical Scandinavian anatomical variations, reducing intraoperative bending requirements and stabilizing distal and diaphyseal fractures efficiently.
High dynamic fatigue limit designed to handle load-bearing requirements, minimizing plate breakage risks even in high-impact sports injury situations common in Norway.
Deep dive into Medisplint Orthopedic Instruments Co., Ltd. - engineering global trust.
Medisplint Orthopedic Instruments Co., Ltd. is a professional manufacturer specializing in orthopedic implants, fixation systems, and surgical instruments for trauma, spine, and joint reconstruction. Founded in 2016, the company has developed steadily with a strong focus on innovation and international expansion. The facility covers approximately 18,500㎡, supporting integrated production, assembly, and quality control operations.
Medisplint reports an annual export revenue of around USD 12 million, with over 7 years of export experience and 10 years of overall industry experience in orthopedic medical device manufacturing. The company operates under strict quality assurance systems including ISO 13485 certification and CE compliance. Quality inspection methods include incoming material inspection, in-process quality control (IPQC), final product inspection (FQC), and third-party laboratory testing. The quality control department consists of 42 dedicated inspectors ensuring product safety, precision, and compliance with international standards.
With a strong global trade background, Medisplint primarily serves markets in Europe, Southeast Asia, the Middle East, and South America. The company collaborates with over 1,200 supply chain partners, supporting stable production capacity and flexible sourcing strategies. Its main customer types include hospitals, orthopedic distributors, surgical centers, and OEM/ODM partners. Medisplint maintains strong R&D capabilities with approximately 85 engineering and development specialists, offering customization options such as private labeling, design modification, and full OEM/ODM solutions. In the past year, the company launched 68 new products, reflecting its continuous commitment to innovation and advancement in orthopedic solutions.
Ensuring the mechanical safety and structural integrity of locking plates and compression screws.
Our in-house biomechanical testing facility guarantees that every implant batch meets the strict dynamic fatigue standards required by orthopedic surgeons in Europe. Using specialized equipment, we evaluate structural properties, wear resistance, torque limit, and ultimate tensile strength. Below is a profile of the specific validation machinery deployed to secure maximum orthopedic reliability:
OEM-certified plating systems for proximal, diaphyseal, and distal fractures, optimized for clinical success in high-demand environments.
Supporting complex trauma cases, upper extremity restoration, and fibular osteosynthesis.
Providing Norwegian distributors and procurement teams with a solid alternative to traditional high-markup logistics models.
Procuring orthopedic implants in Europe has traditionally been dominated by local distributors, which often results in price inflation. Medisplint offers a direct-to-manufacturer supply chain model. By operating a large-scale, automated manufacturing facility in China, we leverage optimal material-sourcing agreements with global titanium suppliers, lowering the manufacturing cost while matching or exceeding the mechanical properties of Western brands.
We maintain an optimized air-freight logistics pipeline directly to major Norwegian hubs (such as Oslo Gardermoen, Bergen, and Trondheim), reducing lead times for non-sterile and custom-ordered configurations to under 14 business days. All products are delivered with complete documentation, including material batch certificates, compliance declarations, and sterile barrier testing records to facilitate fast customs clearance and quality verification upon arrival in Norway.
Essential compliance and product guidance for medical device distributors in Norway.
Optimize your procurement costs and secure a reliable supply of CE MDR compliant titanium locking plates and compression screws tailored for the Norway health system.
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