Orthopedic Implant Manufacturing 

Micron's ISO 13485 certified, FDA registered cGMP orthopedic implant manufacturing solutions include precision machining, finishing, porous coatings, passivation, and sterilization.

Orthopedic Implant Manufacturing Services

Our experienced team enables turnkey production of orthopedic implants and other advanced devices from Micron’s 120,000 square foot manufacturing facility located outside Boston, Massachusetts. Micron’s ISO 13485 certified manufacturing services provide solutions for orthopedic devices ranging from permanent biocompatible device housings to osseointegrated implants, as well as precision-machined removable support structures.

  • Elbows, Acetabular Cups, Femoral Hips, and Unicondylar Knees,
  • Tibial Trays, and Polyethylene Inserts
  • Spinal, Extremity, and Trauma Implants Including Fracture, Compression, Fusion, Screws, Lag Screws, and Nails
  • Pins, Screws, and Access Ports for Chemotherapy and Direct-Application Treatments
  • Dental Implants
  • Orthopedic Instrumentation
orthopedic-implants manufacturing process
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Orthopedic Implants Manufacturing Process

Micron utilizes the most technologically advanced machining and processing capabilities to quickly and accurately produce high-quality orthopedic implants and devices. Different materials and techniques yield varying performance characteristics, and Micron’s extensive experience with a diverse range of materials and products ensures optimal process development based on material characteristics and application requirements. From pre-product launch to high-volume legacy products, our team of engineers works with you to evaluate manufacturability and develop processes optimized to match the phase of product readiness and scale, resulting in cost reduction, yield improvement, and timeline compression.

  • Engineering Team with Expertise in DFM+C
  • Custom 3D Printed Tool Design and Fixturing
  • Supply Chain for Titanium, Cobalt Chrome, Stainless Steel, PEEK, UHMWPE, High-Tech Plastics, Polymers, F-75 Investment Castings, F-999 Wrought Bar, 3D Printed Blanks, and Specialty Coatings
  • Medical Grade 3-Axis, 5-Axis, and 11-Axis CNC Machining (+/- ..0005” ) 
  • Drag Finishing, Tumbling, Polishing, and Hand Mirror Polishing
  • Coating, Plating, Heat Treating and Anodizing 
  • Ultrasonic Cleaning, Citric/Nitric Passivation and Sterilization 
  • High Speed Automation, Assembly, Packaging, and Fulfillment

Quality Management for Orthopedic Implants

Orthopedic implants interface with the human body and require stringent processes to ensure quality and compliance.  As a leading supplier to medical device companies and orthopedic implant OEMs, Micron integrates quality control throughout its entire production process, achieving the highest levels of quality and consistency in the manufacturing of orthopedic implants. Whether working with an innovation start-up or an established medical OEM, quality management systems are co-developed with customers,  with Micron’s engineering team supporting our manufacturing capabilities with process development and validation procedures under the guidelines of ISO 13485. From materials verification to operational validation, and final inspection, each stage of the process is rigorously documented and quality-checked in accordance with customer specifications and FDA requirements.

  • ISO 13485 Compliant, FDA Registered cGMP, and Custom Quality Management Systems
  • IQ/OQ/PQ Validation, Materials Verification; Operational/Design Verification, Operating Scenario Stress Testing
  • Class 7, 8, and 10 Clean Room Manufacturing
  • Micro Engraving, Barcoding, Laser Marking, and Traceability Features
  • Coordinate Measuring Machine (CMM), eCad & Vision Inspection
  • Ultrasonic Cleaning, Citric/Nitric Passivation and Sterilization
iso 13485 orthopedic implant manufacturing