Titanium Alloy Implant Manufacturing
Precision manufacturing of titanium alloy implants with exceptional biocompatibility and mechanical properties for medical applications
Project Overview
Client Requirements
- Biocompatible titanium alloy implants for surgical applications
- Strict dimensional tolerances of ±0.01mm for precise fit
- Medical-grade material (Ti6Al4V Titanium)
- Compliance with ISO 13485 medical device standards
- Production volume of 2,000 units within 8 weeks
Our Solution
- Precision CNC machining with multi-axis capabilities
- Medical-grade Ti6Al4V titanium material procurement
- ISO 13485 certified manufacturing processes
- Advanced quality control with CMM inspection
- Cleanroom packaging and sterilization preparation
Project Success Metrics
Technical Specifications
Material Specifications
| Property | Value |
|---|---|
| Material | Ti6Al4V (Grade 5) Titanium |
| Biocompatibility | ISO 10993 Compliant |
| Hardness | Rockwell C 32-38 |
| Tensile Strength | 900-1050 MPa |
| Yield Strength | 825-950 MPa |
| Elongation | 10-15% |
Dimensional Tolerances
| Dimension | Tolerance |
|---|---|
| Critical Features | ±0.01 mm |
| Secondary Features | ±0.02 mm |
| Surface Roughness (Ra) | 0.2-0.4 μm |
| Cylindricity | 0.01 mm |
| Flatness | 0.005 mm |
| Thread Pitch | ±0.01 mm |
Medical Manufacturing Process
Material Sourcing
Medical-grade Ti6Al4V titanium is sourced from certified suppliers with complete traceability documentation. Material is thoroughly inspected for chemical composition and quality.
Precision Machining
Multi-axis CNC machines with specialized tooling produce complex implant geometries with tight tolerances. Processes are validated and controlled according to ISO 13485 standards.
Surface Treatment
Implants undergo specialized surface treatments to enhance biocompatibility and osseointegration. This includes passivation, anodizing, and/or grit blasting as required.
Quality Control
100% inspection using advanced CMMs, optical comparators, and surface roughness testers. Material traceability and quality documentation are maintained for every implant.
Cleanroom Processing
Implants are processed in ISO 7 cleanrooms to ensure they meet sterility requirements. This includes cleaning, packaging, and preparation for final sterilization.
Documentation
Complete manufacturing documentation is maintained for regulatory compliance, including process validation records, inspection reports, and material certifications.
Results & Benefits
Performance Improvements
-
Enhanced Biocompatibility
Medical-grade Ti6Al4V titanium ensures excellent biocompatibility and osseointegration for successful implant outcomes.
-
Superior Mechanical Properties
High strength-to-weight ratio and corrosion resistance ensure long-term implant durability and safety.
-
Precise Fit
Tight dimensional tolerances ensure implants fit perfectly, reducing surgical time and improving patient outcomes.
Business Benefits
-
Regulatory Compliance
ISO 13485 certified processes ensure compliance with medical device regulations, reducing regulatory risks.
-
Reduced Lead Times
Meeting the 8-week production timeline enabled faster product development and market entry.
-
Improved Quality
Zero defects and rigorous quality control resulted in improved overall product reliability and safety.
Ready to Start Your Medical Project?
Contact us today to discuss your medical device manufacturing requirements and how we can help you achieve regulatory compliance and quality excellence.
Get a Quote