Powerful In-House Factory

Investment casting, CNC machining, and CMM inspection under one roof — 3,000+ m² production area.

Quality Assurance (ISO 13485 / FDA / CE)

Every batch is tracked with full material traceability, chemical analysis, and mechanical testing.

High-Speed Delivery

Lead times as short as 4–6 weeks for standard components, 8–12 weeks for custom OEM parts.

OEM/ODM Design Support

Our engineering team helps you optimize casting geometry, reduce weight, and improve fatigue life.

ERP Integration Ready

We provide digital quality reports and B2B portal access for order tracking, inventory visibility, and documentation.

Global Trade Compliance

We handle FDA registration, CE marking, UKCA, and customs documentation for hassle-free importing.

Total Knee Arthroplasty (TKA)

Femoral condyles and tibial plateaus for primary and revision TKA systems used by knee surgery specialists in the US and EU.

Unicompartmental Knee Replacement

Unilateral tibial plateaus for partial knee replacements — faster recovery, smaller incision, precision fit.

Custom Revision Implants

OEM-designed complex geometry components for patients with bone loss or deformity — CT-to-casting capability.

❓ What certifications do your knee implant components have?

Our factory is ISO 13485:2016 certified, and our components are manufactured to FDA 510(k) and CE MDR standards. We also provide full material traceability per ASTM F75, F136, and F138. For any knee surgery specialist regulatory submission, we supply the complete technical file.

❓ What is the minimum order quantity (MOQ) for custom knee components?

For standard catalog items (tibial plateau, femoral condyle), MOQ is 50–100 pieces. For fully custom OEM designs, MOQ starts at 200 pieces per part number. We offer sample orders (5–10 pcs) for validation before mass production.

❓ How do you handle shipping and import duties for US/EU buyers?

We ship DDP (Delivered Duty Paid) or FOB Tianjin based on your preference. Our logistics team manages customs clearance, FDA prior notice, and CE declaration of conformity. Typical air freight to the US is 5–7 days, sea freight 25–30 days.

❓ Can you match existing implant designs or do we need to share CAD files?

Yes, we can reverse-engineer from physical samples or work from STEP/IGS/CATIA files. Our engineering team performs DFM (Design for Manufacturing) analysis to optimize castability and reduce cost. We sign NDA before any design discussion.

❓ What payment terms do you offer for first-time buyers?

We accept T/T wire transfer, L/C (Letter of Credit), and for established buyers, 30% deposit + 70% against BL. For initial sample orders, we require 100% upfront. We also support Escrow.com for added security.

❓ Do you provide after-sales technical support for knee surgery specialists?

Absolutely. We offer 12-month warranty against manufacturing defects, and our metallurgical engineers are available for video consultations within 24 hours. We also provide on-site audit support for regulatory inspections.

❓ How do you ensure consistent quality across batches?

We follow a strict IQC/IPQC/OQC process: incoming material chemical analysis, in-process dimensional inspection (CMM), and final functional testing. Every batch is traceable with a unique heat number and inspection report. Our rejection rate is below 1.2% across all knee components.