Medisplint
Medisplint
Engineered to surgical-grade standards with Class III CE & ISO certifications
Deep expertise, state-of-the-art facilities, and unwavering dedication to surgical excellence
Medisplint Orthopedic Instruments Co., Ltd. is a premier manufacturing enterprise specializing in the design, development, and high-precision production of orthopedic implants, fixation systems, and specialized surgical instrumentation. Our complete catalog covers solutions for trauma, spine pathology, and joint reconstruction.
Founded in 2016, our trajectory has been characterized by consistent research integration, rigorous manufacturing controls, and international expansion. Our modernized facility covers approximately 18,500 m², supporting a fully integrated manufacturing pipeline that spans from premium raw material evaluation to sterile cleanroom packaging and direct global logistics.
We operate in strict conformance with global standards, boasting comprehensive ISO 13485 compliance and CE certification. Backed by 10 years of industrial experience and 7 dedicated years of international market distribution, Medisplint has earned its standing as a highly trusted manufacturer, exporter, and OEM partner for clinical organizations worldwide.
Our dedicated Quality Assurance division is powered by 42 professional inspectors implementing a multi-stage validation methodology:
Aligning manufacturing capabilities with the stringent demands of international health networks
International distributors and health ministries prioritize implants fabricated exclusively from certified medical-grade titanium alloys (ISO 5832-3) and cobalt-chrome-molybdenum formulations. Suppliers must deliver verified melt-shop test report documentation for traceability.
With the transition from MDD to EU MDR 2017/745 and updated FDA guidelines, suppliers must provide exhaustive Technical Documentation Files (TDF), clinical evaluation data, and rigorous biocompatibility profiles to ensure successful local registration.
Global OEM clients require contract manufacturers capable of weathering microeconomic shocks. With 1,200+ raw material and logistics supply chain partners, Medisplint guarantees continuous material supply and fast, reliable delivery timelines.
Comprehensive clinical hardware matching diverse surgical situations
Modern trauma surgery demands implants tailored to anatomical morphology and biological mechanics. Our internal trauma line features locking plates, variable-angle compression systems, and cannulated compression screws. These elements are designed to optimize stability, reduce bone-contact stress, and preserve critical periosteal blood flow to facilitate accelerated healing.
Complex spinal pathologies and severe joint trauma require extreme mechanical reliability. Medisplint delivers high-grade spine surgical packages including low-profile pedicle screws and kyphoplasty solutions designed to stabilize spinal columns, alongside modular hip prosthesis instrumentation tailored for both human surgical applications and veterinary orthopedic surgery.
Pushing the limits of materials, precision engineering, and surface treatments
Using high-grade medical titanium alloys (Ti-6Al-4V ELI / ASTM F136) and medical stainless steel (316LVM / ASTM F138). These alloys are chosen for their excellent strength-to-weight ratio, fatigue resistance, and biocompatibility, minimizing the risk of adverse tissue reactions.
Implementing advanced electrochemical anodization and SLA (Sand-blasted, Large-grit, Acid-etched) treatments. These modifications alter surface topography to improve osteointegration and provide colored coding, allowing surgeons to quickly differentiate implant sizes during high-stress procedures.
Our in-house biomechanical laboratory is equipped with advanced tensile and fatigue testing machinery. We run extensive static, dynamic, and torsion protocols on all implant lines to ensure compliance with ASTM F1717 (spine) and ASTM F382 (bone plates) standards.
In the past year alone, Medisplint's R&D division launched 68 new products. Supported by 85 dedicated engineering specialists, we continue to research and develop biodegradable magnesium alloys, customized 3D-printed orthopedic porous structures, and anti-microbial surface coatings to minimize post-operative infection risks.
A virtual walk through our advanced production lines, testing facilities, and cleanrooms
Ensuring compliance, regulatory alignment, and reliable supply chain logistics
Every production batch undergoes comprehensive quality testing and is issued a Certificate of Analysis (CoA) matching ISO 13485:2016 protocols. Our documentation supports fast registration and clearance processes with local health authorities.
We offer full OEM and ODM services, including custom anatomical geometries, tailored surgical instruments, private labeling, laser marking, and specialized packaging configured to your market's demands.
With an annual export value of USD 12 million, we are experienced in handling complex international shipping procedures. Our logistics network ensures safe, timely delivery to clients in Europe, Southeast Asia, South America, and the Middle East.
Technical details, compliance answers, and partnership insights for orthopedic buyers
Premium orthopedic solutions designed for specialized surgeries and clinical procedures
