Grai Orthopedic Implants Grai Orthopedic Implants

OEM/ODM Total Knee Replacement Factory & Suppliers

Precision Engineering & Global Orthopedic Manufacturing Excellence

The Future of Orthopedic Manufacturing: OEM/ODM Strategy

In the rapidly evolving global healthcare landscape, the demand for high-precision orthopedic implants, specifically in Total Knee Replacement (TKR) systems, has reached an unprecedented scale. As a premier medical device OEM/ODM manufacturer, we bridge the gap between clinical innovation and industrial-scale production. We operate a facility covering 15,000 m², strictly adhering to ISO13485 standards and maintaining BSCI certification to ensure ethical and quality-controlled output.

15,000 m²

Manufacturing Facility

500+

Skilled Professionals

300+

Product Models

10+

New Products/Month

Technical Roadmap & Future Outlook

Our commitment to excellence extends beyond mere manufacturing. Our R&D team—comprising 8 senior engineers—is constantly pushing the boundaries of orthopedic design. From bio-compatible material selection to the integration of additive manufacturing (3D printing) for custom knee implants, we are preparing our partners for the future of patient-specific care.

We are committed to delivering innovative solutions that reduce surgical trauma, enhance longevity of implants, and improve patient recovery outcomes through advanced surface treatments and metallurgical precision.

Global Compliance & Quality Assurance

We understand that in the medical sector, trust is the primary currency. Our products carry CE, MDR, and FDA certifications, providing our clients with the regulatory backbone required for market entry in the EU, USA, and beyond. Every component undergoes rigorous quality control, from raw material traceability to the final product inspection in our advanced laboratory facilities.

Manufacturing Capabilities:

  • Wire-electrode Cutting
  • High-precision Machining
  • CNC Carving
  • Cleanroom Assembly

Service Pillars:

  • Minor to Full-Scale Customization
  • Comprehensive Traceability Identification
  • One-Year Free Replacement Warranty
  • Global Agency & After-Sales Support

Frequently Asked Questions (FAQ)

What makes your TKR OEM process different?

We don't just act as a factory; we act as an extension of your R&D team. With 300+ existing models and a rapid prototyping capacity, we ensure that your product enters the market faster while meeting stringent international compliance standards.

How do you handle medical device traceability?

Every raw material batch is recorded in our ERP system. From the initial melting point to the final finished product, every stage of production (Machining, Carving, Precision Machining) is digitally tagged and traceable, ensuring 100% compliance with FDA/MDR audit requirements.

What support is provided for international distributors?

We offer agency policy assistance, marketing collateral support, and comprehensive after-sales service, including a free replacement policy within one year of purchase, ensuring your brand maintains the highest reputation with end-users and surgeons.