Grai Orthopedic Implants
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.
Manufacturing Facility
Skilled Professionals
Product Models
New Products/Month
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.
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.
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.
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.
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.