Quality Assurance

  • Comply with ISO 13485 requirements.
  • Hold the approval of FDA 510(k) (USA), CE Marking (European Union), TFDA (Taiwan), NMPA (China), KFDA (Korea), PMDA (Japan), ANVISA (Brazil), 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 has been certified by BSI to ISO 13485. We not only hold the approvals from the CE Mark for European operations and FDA 510(k) approval for North American markets, but also several others around the globe.

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 comparator, coordinate measuring , roundness, roughness, hardness