Quality Assurance

  • Comply with ISO 9001 and ISO 13485 requirements.
  • Hold the approval from FDA 510k (USA), CE Mark (Europe), TFDA (Taiwan), CFDA (China), KFDA (Korea), and other distributed markets.

Innovative Products that Meet World Quality Standards

Since its inception, United Orthopedic has been committed to quality, value and innovative product design. QA teams, comprised of engineers, scientists and QA/QC inspectors, continually monitor operations to ensure compliance with stringent international manufacturing and performance standards. To date, patents issued and patents pending for United Orthopedic Corporation’s value-rich arthroplasty products and instruments total more than 70.

ISO-compliant Quality Management Systems

United Orthopedic Corporation operates Quality Management Systems (QMS) that comply with ISO 9001:2008 and ISO 13485:2003 requirements, as determined by DNV, Norway. We also hold the CE Mark for European operations and FDA 510k approval for North American markets.

Clinically Proven Design

United Orthopedic bases its hip and knee arthroplasty implant and instrument designs on firsthand practitioner input, as well as clinical research and in-depth market studies. To help ensure consistent quality, reliability and efficacy, we perform and manage all critical manufacturing processes in-house, including:

  • Forming: forging and precision casting
  • Cutting: milling, turning, threading, grinding and filing
  • Surfacing: blasting, tumbling, polishing, sintering
  • Thermal treatment:annealing, solution treatment
  • Cleaning, chemical treatment: passivation, electrode polishing, anodizing
  • Inspection: gage instruments, optical compaprator, coordinate measuring maching, roudness, roughness, hardness