Medisplint Medisplint

OEM/ODM Distal Radius Locking Plates Manufacturers & Supplier

Precision-Engineered Volar & Lateral Internal Fixation Systems for Orthopedic Trauma, Clinical Excellence, and Global OEM/ODM Device Solutions

Medisplint Orthopedic Manufacturing Facility Overview

Medisplint Orthopedic Instruments Co., Ltd.

A Premier Strategic Partner for Orthopedic Implant Design, Development, and Contract Manufacturing.

Founded in 2016, Medisplint has emerged as a state-of-the-art developer and manufacturer of advanced orthopedic implants and traumatology instrumentation. Operating from our integrated 18,500㎡ facility, we manage the entire product lifecycle—from raw material verification to high-tolerance precision CNC milling, wire cutting, multi-axis machining, laser engraving, and cleanroom packaging.

With an annual export revenue of over USD 12 million and global distribution in Europe, Southeast Asia, the Middle East, and South America, we are positioned to support implant brands, regional distributors, and clinical institutions through highly adaptive OEM/ODM pipelines.

18,500㎡
Production Space
10+ Yrs
Industry Experience
42
QA Inspectors
85
R&D Engineers
$12M
Annual Export

Biomechanics & Clinical Value of Distal Radius Locking Systems

Engineered to resolve complex intra-articular and extra-articular fractures, ensuring anatomic stability, early mobilization, and optimal patient outcomes.

Clinical Challenge: Distal radius fractures comprise approximately 17.5% of all adult fractures. Instability, osteopenia, and fragmented intra-articular articular surfaces require internal fixation hardware that provides robust load sharing while minimizing soft tissue irritation.

Anatomical Contouring

Low-profile volar plates are pre-contoured to match the watershed line of the distal radius. This design mitigates flexor tendon attrition and subsequent rupture risks, reducing the clinical necessity for hardware removal surgery.

Polyaxial Screw Angles

Variable-angle locking technology allows clinicians to target specific bone fragments up to 15 degrees from the central axis. This dynamic control secures volar rim fragments, styloid processes, and dorsal comminutions.

Load-Bearing Balance

Manufactured from premium Medical-Grade Titanium Alloy (Ti-6Al-4V ELI), our distal radius plates balance high tensile yield strength with a low modulus of elasticity, preventing stress shielding and accelerating bone callus formation.

OEM/ODM Design & Customization Services

Empowering medical device brands and private labels with dynamic engineering, rapid prototyping, and end-to-end global supply chain integration.

Tailored Technical Specifications

Medisplint supports orthopedic brands worldwide through customized dimensional configurations, plate thickness variations, and screw-hole layouts tailored to specific surgical techniques. Our team of 85 design and manufacturing engineers utilizes high-end CAD/CAM modeling software to convert product ideas into commercial-ready devices.

Surface Finish and Color Anodization

Type II anodized surfaces promote biocompatibility. We offer blue, gold, green, and gray finishes for systematic product line differentiation.

Custom Laser Etching & Branding

Direct part marking (UDI barcode systems, brand names, catalogs, and lot numbers) via laser marking centers for traceability.

Sterile & Non-Sterile Packaging

Cleanroom sealing in Tyvek peel pouches or bulk distribution for local sterilization sites, in accordance with ISO 11607 validation guidelines.

Innovative Release Track Record

In the past fiscal year alone, Medisplint successfully introduced 68 new orthopedic implant products to the market. This pace demonstrates our continuous integration of clinical feedback and modern manufacturing protocols.

Global Trade Footprint

By leveraging our roster of over 1,200 supply chain partners, we ensure stable raw material sourcing (complying with ASTM F136 standards) and logistical pathways. This setup reduces supply chain risk for global procurement agents.

Industrial Infrastructure & Raw Processing

Step-by-step preview of Medisplint's orthopedic production lines, where micro-tolerance precision meets industrial capacity.

Rigorous Quality Assurance & Laboratory Evaluation

In accordance with ISO 13485 regulations, Medisplint monitors every stage of manufacturing to confirm implant structural integrity.

Systematic Verification Procedures

Our quality verification starts with raw material inspection (IQC), followed by in-process control (IPQC), final inspection (FQC), and third-party laboratory verification to trace every production batch back to its raw material heat lot.

Dedicated Auditing Team

Our Quality Assurance division employs 42 specialized inspectors managing high-accuracy micrometers, CMM tools, optical systems, and specialized performance testers.

Fatigue & Tensile Validation

We perform cyclical dynamic loading fatigue tests, pull-out resistance tests, and shear testing to meet or exceed FDA and CE trauma system requirements.

Global Procurement & Supply Chain Resiliency

Providing strategic support for orthopedic medical device purchasers, distributors, and surgical centers worldwide.

Optimized Stocking & Logistics

Understanding local hospital logistics helps minimize supply delay risks. We maintain raw stock allocations for high-demand sizes (e.g., 3-hole, 4-hole, and 5-hole volar styles) to support shorter production cycles and shipping timelines.

Regulatory Document Support

Medisplint simplifies regional regulatory filings by supplying complete technical dossiers, Certificate of Free Sale (CFS) materials, ISO 13485 test logs, and biocompatibility verification certificates.

Clinical and Technical Support

We supply surgical instrumentation kits, sterilization trays, and instructional surgical guides to ensure surgical teams have everything needed for implant placement.

Technology Roadmap & Future Outlook

Innovation plans focusing on material science, biomechanics, and manufacturing automation.

Biodegradable & Bioactive Alloys

We are investigating zinc and magnesium-based implants that degrade gradually under controlled conditions, potentially reducing the need for follow-up surgeries.

Automated Production Lines

Expanding our CNC milling centers with smart robotics to support 24/7 dark-factory operations and maintain high precision for high-volume orders.

Additive Manufacturing (3D Printing)

Developing electron beam melting (EBM) titanium printing lines to manufacture custom, patient-specific orthopedic implants for reconstructive surgery.

Seeking OEM/ODM Solutions?

Contact our engineering and sales representatives for technical drawings, material certifications, and product pricing information.

Contact Our Engineers

Frequently Asked Questions (FAQ)

Get answers to common queries regarding regulatory compliance, manufacturing capacity, design modifications, and shipping timelines.

What materials are used in Medisplint Distal Radius Plates?
Our implants are manufactured from pure titanium (grades 2 and 4) or biocompatible titanium alloys (typically Ti-6Al-4V ELI conforming to ASTM F136 specifications), which provide high fatigue strength and mechanical stability.
Do your manufacturing processes comply with ISO and CE regulations?
Yes. Medisplint operates under a certified ISO 13485 quality management system. Our trauma systems comply with European CE regulations, allowing distribution across various global markets.
What is the typical lead time for custom OEM/ODM implant batches?
Standard OEM production runs generally take 30 to 45 days, depending on batch volume and design complexity. Fully customized ODM projects requiring mold changes or unique tooling setups may require 60 to 90 days.
Can you provide complete trauma instrumentation kits with the plates?
Yes. We offer fully configured surgical tool sets that include drill guides, bone taps, screwdrivers, plate benders, and depth gauges, along with sterilization trays for clinical use.
Do you offer private labeling (custom laser engraving and packaging)?
Yes. We provide complete labeling services, including laser marking and custom-printed sterilization pouches, to help clients comply with regional tracking and traceability guidelines.