Medisplint
Medisplint
Premium trauma implants and customized surgical instrument systems designed for high-precision clinical operations.
In modern traumatology, proximal femoral fractures present a major clinical challenge, particularly in aging demographics where osteoporotic bone conditions compromise implant anchorage. The Proximal Femoral Nail Antirotation (PFNA) has emerged as a clinical benchmark, utilizing a helical blade configuration to compact bone stock instead of removing it. This biomechanical enhancement significantly increases structural load-sharing and limits cut-out rates compared to traditional lag screw assemblies.
Our collaborative design pipeline optimizes the structural attributes of PFNA nails. Through finite element analysis (FEA), the mechanical distribution of stress is carefully modeled. Dynamic stresses are distributed throughout the cannulated implant body to reduce stress shielding in the femur. The manufacturing process maintains tolerances within ±0.01mm, ensuring a precise match with locking end caps and distal bolts.
An established industry pioneer providing end-to-end manufacturing solutions for orthopedic trauma, spinal fixation, and joint reconstruction.
Founded in 2016, Medisplint Orthopedic Instruments Co., Ltd. has developed into a major provider of OEM/ODM solutions for international orthopedic brands. With over 10 years of manufacturing experience and a decade of design expertise, our production facilities feature modern CNC machining blocks and cleanroom packaging spaces. We manage a complex global logistics chain, shipping to distributors, hospitals, and surgical networks across Europe, Southeast Asia, the Middle East, and South America.
Detailed look at our modern manufacturing steps, computerized CNC machining centers, and comprehensive mechanical testing labs.
Our OEM/ODM process provides orthopedic trauma device buyers with structured development milestones. We transition your concepts or functional designs into CE/FDA compliant product lines, using rigorous physical testing to verify clinical safety and efficacy.
We work with hospital teams or medical distributors to modify design details (such as nail diameter variations, custom CCD angles, or specialized distal slots) using parametric CAD software.
All load-bearing implants undergo 5 million cycles of dynamic fatigue testing on our in-house testing equipment, satisfying ASTM F382 or ISO 14801 standards for load and performance.
We handle cleanroom packaging validation, EO sterilization parameters, laser marking with Unique Device Identifiers (UDI), and provide complete regulatory documentation to support registration.
Entering international healthcare markets requires adherence to local medical device regulations. Medisplint maintains a strict ISO 13485 quality management system, enabling streamlined regulatory pathways across different regions.
Our regulatory team prepares specialized dossiers matching regional guidelines, such as the EU Medical Device Regulation (MDR 2017/745), regional FDA pathways, and various local MOH registrations. We supply clinical evaluation reports, biocompatibility datasets (ISO 10993), and sterilization validation studies to streamline local customs clearance and hospital tender requirements.
With a network of 1,200 supply chain partners, we ensure consistent raw material sourcing, even during market disruptions. We provide buffer stock programs and flexible scheduling options for critical trauma components, helping global distributors maintain dependable supply lines.
Answers to common questions regarding our OEM/ODM capabilities, PFNA manufacturing specifications, and regulatory options.
Explore our wider range of spinal fixation plates, locking plates, navigation machinery, and microsurgical tools.
