Everything You Need to Know About Sourcing Orthopedic Implants
Explore authoritative answers regarding manufacturing qualifications, OEM/ODM processes, quality control standards, sterile packaging, and international shipping logistics.
Are you a trading company or a direct medical device manufacturer?
Orthi Medical Co., Ltd. is a direct manufacturer specializing in orthopedic implants, surgical instruments, and minimally invasive device solutions since 1994.
Our primary manufacturing facility is located in Jinhua City, Zhejiang Province, East China (approximately 2 hours via high-speed railway from Shanghai). We operate state-of-the-art CNC machining centers, automated polishing stations, and certified 100,000-class cleanrooms to control quality, traceability, and lead times from raw titanium bars to finished sterile packages.
What international certifications and quality management systems do your products hold?
Orthi Medical Co., Ltd. operates under strict global quality assurance guidelines to ensure medical compliance for registration in international markets:
- ISO 13485 & ISO 9001: Certified quality management systems for medical device design and production.
- CE Marking: Conformity certification for European and international health and safety directives.
- Material Compliance: All implant raw materials adhere strictly to international standards, including pure titanium (ASTM F67 TA2/TA3) and titanium alloy (ASTM F1472 Ti-6Al-4V TC4) with tensile strength ≥930 MPa.
What is your full product range for international healthcare sourcing?
We manufacture a complete portfolio covering multiple surgical disciplines, allowing distributors to consolidate sourcing under one vendor:
- Trauma Fixation: Locking plates, intramedullary nails (PFN, tibia, femur), cannulated compression screws, and titanium rib plates.
- Spine Systems: Thoracolumbar pedicle screw systems, PEEK interbody fusion cages (PLIF, TLIF, Cervical PEEK-Z), anterior cervical plates, and kyphoplasty systems.
- Sports Medicine: PEEK suture anchors, all-inside ACL/PCL reconstruction drill guides, shaver blades, and meniscal repair cannulae.
- Hip & Knee Arthroplasty: Cementless/cemented femoral stems, acetabular cups, ceramic/polyethylene liners, and artificial knee joint components.
- Minimally Invasive Imaging: Unilateral Biportal Endoscopy (UBE) instrument sets, 4K endoscopy camera towers, and RF plasma ablation probes.
- Stents: Bare metal coronary stents and Double J ureteral stents.
Do you offer OEM, ODM, and custom private-label services for global brands?
Yes. Orthi Medical Co., Ltd. provides complete drawing-based OEM and contract manufacturing services for international orthopedic medical device brands and major regional distributors.
Our OEM engineering team assists with CAD/CAM prototyping, dimensional testing, customized surface color anodizing, laser marking (UDI code printing), custom surgical instrument tray design, and complete technical dossier assembly for regulatory approval in your market.
Can implants be delivered in pre-sterilized packages?
Yes. We offer individual sterile packaging for bone screws, bone plates, intramedullary nails, and cannulated screws.
Implants are packaged inside medical-grade Tyvek pouches within 100,000-class cleanroom environments and sterilized via Co-60 gamma irradiation to guarantee a Sterility Assurance Level (SAL) of 10-6. Sterile-packed implants reduce hospital reprocessing expenses, lower infection risks, and facilitate direct OR convenience.
What are your standard delivery lead times and international shipping methods?
We work with leading international courier networks (DHL, FedEx, UPS) as well as air and sea freight forwarders to ensure safe global delivery:
- In-Stock Catalog Items: Dispatched within 7 to 15 business days upon order confirmation.
- Regular OEM / Mass Production: Typically delivered within 30 to 45 business days depending on order volume and technical specifications.
- Packaging: All goods are packaged with shockproof and humidity-resistant packaging suitable for long-distance export transit.
Do you support regional distributors with technical training and academic support?
Yes. We actively build long-term partnerships with medical device distributors. We offer comprehensive support, including step-by-step surgical technique guides, clinical CAD illustrations, product video tutorials, online training webinars, and local workshop support.
If you are interested in becoming an authorized distributor for Orthi Medical Co., Ltd. in your country or region, please get in touch with our commercial sales team.
Are sample orders available for technical evaluation?
Yes. We welcome prospective distributors and OEM clients to request product samples for dimensional verification, mechanical testing, and surgeon evaluation. Sample orders can be customized according to your required specifications and engineering drawings.
What are your standard commercial payment terms?
Our primary payment method is Telegraphic Transfer (T/T). For contract-based bulk orders, Irrevocable Letters of Credit (L/C at sight) can also be arranged. Detailed payment schedules and proforma invoices are provided upon order finalized with our sales manager.
How can procurement managers request a formal quotation or technical catalog?
You can send your product inquiries, engineering drawings, or RFP requirements directly to our export team via email at [email protected]. Our international business specialists respond to all technical and commercial inquiries within one business day.
Have Additional Sourcing Questions or Technical Requests?
Contact Orthi Medical Co., Ltd. today to discuss custom OEM machining, sterile implant packaging, or regional distribution opportunities.