Medisplint Medisplint

OEM/ODM Trauma Instrument Sets Supplier & Exporter

High-Precision Orthopedic Solutions & Advanced Contract Manufacturing Systems (ISO 13485 & CE Compliant)

GLOBAL LEADERSHIP

Medisplint Orthopedic Instruments Co., Ltd.

Founded in 2016, Medisplint Orthopedic Instruments Co., Ltd. has established itself as an elite manufacturer and global exporter specializing in high-precision orthopedic implants, internal fixation systems, and specialized surgical instruments. Serving trauma surgery, spine stabilization, and joint reconstruction, we provide comprehensive manufacturing pipelines optimized for international distributors and hospital groups.

Our state-of-the-art facility spans over 18,500m², facilitating vertically integrated production. With over 10 years of domestic medical device manufacturing experience and 7+ years of dedicated global export experience, we manage an annual export turnover of USD 12 million. By coordinating with over 1,200 supply chain partners, we ensure consistent raw material acquisition and rapid turnarounds for customized products.

18.5k㎡
Production Facility
10+ Yrs
Industry Experience
$12M
Annual Export Rev.
85+
R&D Specialists
Medisplint Factory Infrastructure and Assembly Operations

Global Trauma Procurement & Strategic Sourcing Shifts

Analyzing key market drivers, clinical preferences, and technical dynamics shaping purchasing decisions.

Clinically Driven Customization

Modern trauma surgeries rely heavily on anatomically pre-contoured plates that minimize intraoperative bending. Sourcing departments prioritize suppliers capable of modifying plate geometries and screw hole placement to fit specific demographic morphologies.

Material Compatibility & Biocompatibility

The selection of raw materials is vital. B2B buyers mandate verified Grade 5 Titanium (Ti6Al4V ELI) and medical-grade stainless steel (316LVM) to avoid implant failure and ensure high corrosion resistance and structural fatigue limits.

Complete Instrument Integration

Distributors prefer purchasing unified instrument sets that include all necessary drills, taps, screwdrivers, and depth gauges. Modular tray layouts with clear laser-etched sizes reduce the clinical learning curve and streamline operating room setup.

Vertical OEM/ODM Manufacturing Processes

From slitting and milling to sub-micron quality inspections, our facility controls every phase of the manufacturing workflow.

Leveraging high-end CNC machining centers, automated slitting devices, and professional finishing lines, Medisplint guarantees repeatable manufacturing tolerances of <5 microns. Our production department works directly with design engineers using SolidWorks and CAD modeling platforms to rapidly transition clinical ideas into production-ready physical instrumentation.

Slitting Raw Materials
Slitting Process
CNC Machining Center
CNC Machining
Machining Operations
Precision Machining
Milling operations
Milling
Inspection and Packing Area
Inspection & Packing
Secondary Inspection & Packaging
Quality Sorting
Warehouse and Logistics Center
Warehouse & Logistics
Slitting Machine Hardware
Slitting Machine
High speed CNC Machining Center
CNC Center
CNC Milling Machine details
CNC Milling
Wire Cutting Machine
Wire Cutting
CNC Lathe unit
CNC Lathe
Laser Marking Machine
Laser Marking
CAD/CAM Design department
R&D & Design

In-House Testing Facility & Quality Management

A rigorous quality assurance department staffed by 42 inspectors, ensuring traceablity across all critical parameters.

Medisplint operates under a strict quality management system aligned with ISO 13485:2016 and CE protocols. We run full-scope testing labs that conduct tensile, fatigue, torsional, and dimension metrological inspections. Our testing laboratory guarantees that any device exiting the facility satisfies ASTM and ISO international standards for orthopedic trauma implants.

Internal Quality testing Lab
Testing Lab
Inspection and metrology station
Quality Inspection
Secondary QC Station
Metrology Room
Fatigue Testing equipment
Fatigue Tester
Tensile testing machine
Tensile Tester
Two Dimensional Measuring Instrument
2D Optical Measurement
Hardness tester
Hardness Tester
Bone Screw Performance testing unit
Bone Screw Performance Tester

Localized Compliance Support and Export Auditing

Entering international medical markets requires deep regulatory compliance. We provide full technical documentation dossiers (STED) to assist in product registration with national health organizations, including the European Union Medical Device Regulation (EU MDR), Food and Drug Administration (FDA) 510(k), ANVISA (Brazil), and regulatory authorities across the Middle East and Southeast Asia.

R&D Innovation Roadmap

In the past calendar year, Medisplint's engineering division successfully designed and introduced 68 new products to our global catalog. Our forward-looking design philosophy centers on:

  • Anatomical Pre-contouring: Optimizing plates to minimize intraoperative modification and preserve periosteal blood supply.
  • Minimally Invasive Surgery (MIS) Tooling: Designing target-tracking sleeve guides for percutaneous plate insertion.
  • Smart Surgical Power Systems: Upgrading power drills with brushless motor configurations and autoclavable lithium batteries.

Regulatory & Technical FAQ

Important details on OEM/ODM service terms, medical-grade materials, and our production capacities.

1. What is the typical lead time for custom OEM/ODM trauma sets?
For custom design modifications (e.g., changes to plate profile or screw configurations), the typical cycle takes 4 to 6 weeks from technical drawing finalization to pilot production. Complete new product designs (including custom toolsets) can take 8 to 12 weeks depending on complexity.
2. Which medical-grade raw materials do you use for implants and instruments?
Our trauma implants are machined from Grade 5 Titanium Alloy (Ti6Al4V ELI) complying with ASTM F136 or medical-grade Stainless Steel 316LVM (ASTM F138). Surgical instruments and drive assemblies are made of hardened Martensitic Stainless Steels (e.g., 420, 630/17-4PH) to maintain cutting edges and high torsion resistance.
3. Do you supply technical documentation for CE and national registry submissions?
Yes, our regulatory affairs department supplies complete documentation, including raw material certificates, biocompatibility test results, mechanical evaluation reports (fatigue/torsion), sterilization validations, and clinical evaluation files (CER).
4. How is the sterilization capability of your instrument trays verified?
Our instrument trays and sterilization cases are constructed of PPSU or medical-grade anodized aluminum. They are validated to withstand repeated autoclave runs (134°C steam sterilization) without material degradation, ensuring reliable sterilization cycles.
5. What is the MOQ (Minimum Order Quantity) for private labeling?
MoQs vary by item. For standard trauma plates and screws, the MOQ is 50-100 units. For complete specialized instrument kits, we accept trial batches starting at 10-20 sets. We aim to support distributors expanding their local footprints.