Medisplint
Premium titanium bone implants and specialized surgical instrumentation certified for international healthcare facilities.
Medisplint Orthopedic Instruments Co., Ltd. is a leading, professional manufacturer specializing in orthopedic implants, fixation systems, and high-precision surgical instruments tailored for trauma, spine, and joint reconstruction. Established in 2016, our enterprise has witnessed exponential growth driven by relentless engineering innovation, a rigid quality assurance framework, and strategic international market expansion.
Our state-of-the-art facility spans over 18,500 square meters, integrating R&D centers, ISO Class 7 cleanrooms, and high-precision Swiss-CNC machining lines under one roof. Driven by a global footprint, we record an annual export volume exceeding USD 12 million, partnering with medical device distributors, hospitals, and surgical centers in Europe, South America, the Middle East, and Southeast Asia.
A comprehensive overview of commercial demand, clinical utility, and material sciences driving the spine surgery market.
Cannulated pedicle screws represent the technological cornerstone of Minimally Invasive Spine Surgery (MISS). Unlike traditional solid pedicle screws, cannulated variants possess a hollow central core. This design permits them to be passed directly over a pre-placed Kirschner wire (K-wire) or guidewire, allowing surgeons to achieve pinpoint insertion precision while minimizing soft tissue retraction, bleeding, and overall patient recovery periods. The global market value for spinal implants is projected to expand significantly, driven by a growing aging population, rising incidences of degenerative disc disease, and the rapid shift from open surgeries to minimally invasive techniques.
For B2B procurement professionals, orthopedic distributors, and global hospital networks, choosing a dependable OEM/ODM Cannulated Pedicle Screws Factory is not merely a matter of unit economics. It requires verification of raw material purity (such as ASTM F136 compliant Titanium Alloys), micro-machining tolerances, thread pitch geometries, and extensive fatigue test reports to comply with regulatory standards like the European MDR and US FDA 510(k).
We source only premium Ti-6Al-4V ELI (Extra Low Interstitial) medical-grade titanium. This material ensures optimal biocompatibility, extreme tensile strength, and superior osteointegration properties, making it safe for permanent spinal fixation.
Our engineered pedicle screws feature advanced dual-lead thread geometries. This design dramatically accelerates insertion speed, reduces torque demand on surgeons, and maximizes pull-out strength in both cortical and cancellous bone structures.
With precise inner lumen concentricity and tight diameter tolerances, our cannulated screws guarantee frictionless passage over 1.2mm to 1.6mm K-wires. This reduces surgical friction and prevents binding during critical positioning phases.
Tailored OEM/ODM engineering parameters engineered to support diverse patient anatomies and clinical needs.
| Implant Parameter | Standard Specification Range | OEM/ODM Customization Capability | Clinical Advantages |
|---|---|---|---|
| Screw Diameter | Ø 4.5mm, 5.5mm, 6.5mm, 7.5mm, 8.5mm | Custom micro-diameters & pediatric sizes available | Matches pedicle anatomy across cervical, thoracic, and lumbar vertebrae. |
| Cannulation Diameter | Ø 1.5mm - 2.0mm inner channel | Adjustable inner lumen for specialized guide tools | Allows smooth, bind-free tracking over guide wires during MIS. |
| Screw Length | 25mm to 80mm (in 5mm increments) | Extended lengths for complex deformity correction | Provides multi-level options for varying spinal structures and patient heights. |
| Head Design | Polyaxial (up to 60° range of motion), Monoaxial | Uniplanar, dual-head, low-profile designs | Simplifies rod insertion and reduces stress concentrations on anatomical sites. |
| Surface Finish | Anodized (Color-coded by size), Acid-etched | Bio-active coating (HA, Porous Titanium Spray) | Color coding prevents surgical selection errors; coatings promote rapid bone bonding. |
Transparency in manufacturing: Step-by-step documentation of our CNC machining, verification, and preparation workflows.
Verifying safety, tolerances, and mechanical fatigue through systematic laboratory inspections.
In spinal surgery, hardware failure is not an option. Medisplint enforces an uncompromising multi-stage quality control protocol driven by a specialized team of 42 QC inspectors. From raw material spectrum analysis to axial pull-out and torsional shear testing, every batch of OEM/ODM cannulated pedicle screws is validated to withstand physiological loading patterns over long periods. Below is a tour of our testing infrastructure, where each device undergoes mechanical stress analysis to guarantee compliance with international standards.
Unlocking significant lead time, quality, and cost advantages through advanced industrial ecosystems.
China's medical manufacturing hubs offer unprecedented geographic integration. Raw titanium suppliers, precision tool makers, anodizing facilities, and sterile packaging vendors operate in close proximity. This geographic clustering dramatically shortens material transit times, minimizes logistics overheads, and allows us to rapidly scale production to meet sudden demand increases.
Equipped with high-precision Swiss-type lathes, multi-axis machining centers, and automated optical checkers, our production lines maintain tolerances as low as ±0.005mm. This high level of automation reduces manual variability, lowers scrap rates, and delivers stable, cost-effective pricing for complex profiles compared to Western manufacturing alternatives.
Key procurement and technical insights for distributors, agents, and surgical product managers.
All our cannulated pedicle screws are manufactured using medical-grade Titanium Alloy (Ti-6Al-4V ELI) conforming to the ASTM F136 specification. We provide complete chemical composition analysis reports, tensile strength data sheet certifications, and material traceability documents from raw titanium bars to finished implants with every batch shipped.
Yes. Our in-house team of 85 R&D engineers supports comprehensive OEM/ODM customization. We can adjust outer/inner diameters, modify thread profiles (such as buttress, cortical, or cancellous patterns), implement specialized polyaxial range of motion heads, and apply custom surface anodization colors or HA coatings. We sign NDA (Non-Disclosure Agreements) to protect proprietary intellectual designs.
Our quality assurance workflow spans from incoming material testing to final shipment checkouts. Every manufacturing batch undergoes 3D dimensional inspections, concentricity testing of the central lumen, and fatigue testing according to ASTM standards (such as ASTM F1717 for spinal implant constructs). Our cleanroom packaging processes conform to ISO 13485:2016 regulations to ensure sterility and safety.
Standard prototype manufacturing and tooling adjustment for custom designs takes about 15 to 30 days. Regular bulk production runs are typically completed and ready for shipment within 30 to 45 days, depending on batch quantities and surface treatment specifications.
Yes, we design and manufacture both human-grade implants and veterinary-specific surgical kits. Our specialized orthopedic cannulated instrument sets, drill guides, and bone screws are widely utilized in veterinary hospitals for complex spinal decompression and fixation procedures.
Complete surgical kits, orthopedic drills, external fixation frames, and revision instruments supporting spinal procedures.