About Orthi Medical

Orthi Medical Manufacturing Facility and Precision CNC Cleanroom
Pioneering Orthopedic Excellence

Who We Are

Founded in 1994, Orthi Medical Co., Ltd. has established itself as a global leader in the design, engineering, and manufacturing of orthopedic implants, surgical instrument sets, and minimally invasive device solutions.

With over three decades of medical device manufacturing experience, Orthi Medical Co., Ltd. operates state-of-the-art 5-axis CNC machining centers, automated surface finishing lines, and Class 100,000 cleanroom assembly facilities. We serve as a trusted partner and contract manufacturer for top international medical brands, healthcare institutions, and surgical device distributors across more than 60 countries.

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Advanced Manufacturing Capabilities

Technology for Health

We continuously invest in state-of-the-art production infrastructure, precision quality control testing systems, and specialized metallurgical processing to ensure every implant fulfills rigorous mechanical and biological performance benchmarks.

  • Medical-Grade Materials: Certified Ti-6Al-4V ELI (ASTM F1472), Pure Titanium (ASTM F67), PEEK-OPTIMA®, CoCrMo, and UHMWPE.
  • Precision Surface Engineering: Type II/III Anodization color-coding, SLA (Sandblasted, Large-grit, Acid-etched) osteo-conductive treatments, and HA porous coatings.
  • Sterile Packaging Solutions: ISO Class 7 cleanroom packaging with Co-60 Gamma irradiation processing guaranteeing Sterility Assurance Level SAL 10-6.
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Precision Machining of Orthopedic Implants
Integrated Sourcing Solutions

Wide Range of Orthopedic & Surgical Solutions

Orthi Medical Co., Ltd. develops comprehensive product portfolios tailored for global medical distributors, tender suppliers, and hospital procurement departments.

Trauma Fixation Systems

Anatomical locking compression plates, intramedullary nails, cannulated compression screws, and external fixators designed for complex fracture care.

Spinal Fixation & Interbody Fusion

Pedicle screw systems, PEEK cervical & lumbar cages, anterior cervical plates, and minimally invasive balloon kyphoplasty kits.

Sports Medicine & Arthroscopy

PEEK and titanium suture anchors, all-inside ACL/PCL reconstruction drill guides, meniscal repair devices, and high-durability shaver blades.

Joint Arthroplasty (Hip & Knee)

Cementless HA-coated femoral stems, primary acetabular cups, ceramic/HXLPE liners, bipolar heads, and total knee joint replacement systems.

Minimally Invasive Endoscopy & UBE

Unilateral Biportal Endoscopy (UBE) instrument sets, 4K Ultra HD surgical camera towers, transforaminal spinal endoscopes, and RF plasma probes.

Stents & Sterile Packages

Bare metal coronary stents, high-pressure NC balloon catheters, Double J ureteral stents, and SAL 10-6 gamma-sterilized ready-to-use implants.

International Compliance

Global Quality Assurance System

Orthi Medical Co., Ltd. operates a full-scale Quality Assurance System under ISO 9001 and ISO 13485 standards. Our manufacturing processes adhere to stringent international regulatory guidelines, including CE marking and FDA CFR 820 audit readiness.

Every product batch undergoes 100% optical CMM dimensional verification, mechanical testing, and full raw material certificate traceability from raw titanium bar stock to sterile release.

ISO 13485Medical Devices QMS
ISO 9001Quality System
CE MarkEuropean Compliance
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ISO 13485 Quality System Certificate - Orthi Medical Co., Ltd.
Contract Manufacturing

OEM & ODM Partnership Workflow

Orthi Medical Co., Ltd. collaborates closely with international medical brands to convert CAD engineering designs into market-ready implants and customized instrument trays.

1

Design & DFM Review

Engineering review of client CAD models, raw material selection, and tolerance feasibility analysis within 24 hours.

2

Prototyping & Mechanical Testing

Precision CNC machining of initial samples, dimensional CMM inspection reports, and fatigue testing compliance.

3

Automated Mass Production

High-volume Swiss-lathe turning, 5-axis milling, laser marking, color anodizing, and batch traceability logging.

4

Sterile Packaging & Regulatory Support

Private label packaging, ISO Class 7 cleanroom sealing, Co-60 gamma sterilization, and complete technical dossier files for market registration.

Partner with a Leading Orthopedic Manufacturer

Looking for reliable OEM solutions, custom instrument trays, or certified orthopedic implants? Contact Orthi Medical Co., Ltd. at .

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