Titanium in Medical Devices: Implants, Instruments & Regulatory Guide

Titanium is the gold standard for medical devices because it is the most biocompatible metal available. Human bone bonds directly to titanium without rejection. Four key properties make it essential: biocompatibility through spontaneous TiO2 oxide layer, low elastic modulus of 110 GPa reducing stress shielding, corrosion resistance in chloride-rich body fluids, and non-magnetic properties for MRI safety. Grades: Gr2 CP (ASTM F67, 345 MPa) for soft tissue mesh and non-load-bearing implants. Gr4 CP (ASTM F67, 550 MPa) for dental implants and small bone plates. Gr23 ELI (ASTM F136, 828 MPa) for load-bearing orthopedic implants including hips, knees, spine, and trauma fixation. Standard Gr5 (ASTM B348) for surgical instruments only, never for implants. Orthopedic applications: hip stems, knee components, spinal cages, bone plates. Dental: Gr4 implants with SLA surface treatment for accelerated osseointegration. Cardiovascular: stent components, heart valve frames, pacemaker housings. Regulatory: US requires F67/F136, EU requires ISO 5832-2/3 with ISO 13485 QMS. Ylasting Titanium supplies ASTM F136 Gr23 ELI and ASTM F67 CP grades with full documentation. Contact us for medical-grade titanium.