Horaizon Orthopedic Implants Horaizon Orthopedic Implants
Global Orthopedic Implants & Systems Manufacturer

Custom OEM Orthopedic Braces Manufacturers & Factory

Precision orthopedic external fixators, spinal pedicle screw systems, custom medical implants, and premium surgical instrument kits certified under ISO 13485.

Zhejiang Horaizon Medical Device Co., Ltd.

Zhejiang Horaizon Medical Device Co., Ltd. is an integrated high-tech enterprise combining development, advanced manufacture, global sales, and comprehensive customer support, specializing in the field of premium orthopedic medical devices and high-precision stabilization systems.

Our facility is equipped with state-of-the-art production machinery optimized for high-precision, large-scale medical-grade component manufacturing alongside a comprehensive suite of precision testing systems. Led by a highly skilled R&D team, our technical development aligns with global healthcare progress. All manufacturing, validation, and administrative systems strictly follow international benchmarks: ISO 9000 / ISO 13485 International Quality System Standards and the YY/T0287 Medical Device Quality System Standard.

We focus on delivering stable, advanced medical technologies that offer clinicians simpler, more intuitive functional operation. By practicing our core corporate values—"Precision, Professionalism, Innovation"—we actively foster human health and long-term vitality through clinical-grade hardware and reliable supply services.

Zhejiang Horaizon Medical Device Production Facility

Advanced Manufacturing Capabilities & Production Workflow

We provide end-to-end medical contract manufacturing, utilizing advanced materials like Medical Grade 5 Titanium (Ti-6Al-4V ELI), PEEK polymers, and implant-grade stainless steel to deliver consistent clinical solutions.

Rough Machining Stage
Rough Machining
Finish Machining Stage
Finish Machining
Inspection Stage
Inspection
3D Printing Stage
3D Printing
Three Coordinate Detection Stage
Three Coordinate Detection
Packing Stage
Packing
Turning Center Stage
Turning Center
Machining Center Stage
Machining Center
3D Metal Printer Stage
3D Metal Printer
CNC Lathe Stage
CNC Lathe
CMM Stage
CMM (Coordinate Measuring Machine)
Image Analyzer Stage
Image Analyzer

Global Enterprise Procurement & Custom OEM Supply

As a medical device manufacturer, we address the procurement challenges of international medical brands, regional distributors, and healthcare systems.

Strict Quality Gateways

Every batch of raw titanium and stainless steel is tracked with Material Test Reports (MTR) and chemical analysis. Certified cleanroom packaging ensures devices arrive sterilized or cleanroom-ready for immediate clinical processing.

Flexible OEM/ODM Capabilities

We convert CAD designs and radiological scans into anatomical orthopedic braces and surgical implants using high-precision CNC multi-axis milling, Swiss-turning, and advanced 3D metal printing.

Supply Chain & Logistics

Located in Zhejiang's manufacturing corridor, we leverage direct logistics connections to the Ningbo and Shanghai deepwater ports, simplifying customs and shipping processes for global distributors.

15+
Years Manufacturing Experience
100%
Traceable Raw Materials
50+
Exporting Countries Served
0.02mm
Machining Tolerance Precision

Compliance & Local Regulation

Navigating different national regulations is critical for global distributors. Our production processes conform to CE directives and ISO 13485 (Medical Devices Quality Management). We maintain clean production and comprehensive validation folders to support our partners' regulatory registration processes.

We ensure compliance via mechanical stress profiling, biological safety reviews, and material traceability audits, minimizing regulatory risks for orthopedic devices and surgical implants.

Technological Advancements

We continue to invest in key technological developments to address changing clinical needs:

  • Additive Manufacturing: 3D-printed porous implants that mimic natural trabecular bone configurations.
  • Advanced Surface Coatings: Using ALD and CVD methods to deposit protective films and biological agents.
  • Bio-compatible Polymers: Carbon-fiber PEEK components for radiolucent spinal cages and bone fixation.

Clinical Application Scenarios

Our solutions support a wide range of clinical orthopedic and stabilization situations:

  • Trauma & Reconstructive Surgery: Fixators and anatomical bone screws for stable fracture alignment.
  • Spinal Interventions: Pedicle screws and interbody fusion cages designed to preserve alignment.
  • Industrial Rail Systems: Durable castings and track shoulders engineered to withstand extreme mechanical loads.

The Custom OEM Lifecycle

Our design, validation, and production process ensures all custom medical components and orthopedic assemblies meet necessary requirements.

1. Collaborative Design & Prototyping

Our engineers partner with your clinical development team, translating CAD files and sketches into prototypes. This phase utilizes 3D printing for shape and volume verification.

2. Process Validation & Metallurgy

We review chemical analysis records of titanium and stainless steel raw stock. Initial trial production steps are simulated on CNC machining centers to verify surface finishes.

3. High-Precision Mass Production

Our turning centers, multi-axis milling machines, and 3D metal printers produce the components, ensuring consistent quality for large production runs.

4. Three Coordinate Detection & Quality Control

Quality specialists inspect dimensions on our Coordinate Measuring Machines (CMM) and Image Analyzers to ensure they meet specified tolerances.

Technical FAQ: Orthopedic OEM and Production Logistics

Detailed answers regarding our medical manufacturing processes, logistics, and quality management standards.

What materials are typically used for orthopedic trauma and spinal implants?

We mainly use biocompatible materials, including Medical Grade 5 Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136, Implant-Grade Stainless Steel (316LVM) conforming to ASTM F138, and Polyetheretherketone (PEEK) for spinal interbody cages. These materials offer suitable mechanical strength, corrosion resistance, and bio-compatibility.

How does Zhejiang Horaizon guarantee the dimensional tolerances of custom external fixators?

We maintain precise control over our turning and machining centers. Quality checking is managed using our CMM (Coordinate Measuring Machine) systems and high-magnification Image Analyzers, ensuring dimensional conformance down to +/- 0.01mm.

Does your factory support full OEM customization and instrument set assembly?

Yes. We offer contract manufacturing from raw component fabrication to packaging design. We produce both custom implants and complete surgical instrument sets, helping hospitals and distributors source integrated surgical systems.

What quality management certifications does your facility hold?

Zhejiang Horaizon operates under ISO 13485, ISO 9000, and YY/T0287 medical device quality management regulations. We provide material tracking documentation, dimension inspection reports, and sterilization-ready packaging options.