EASYMADE-TI

EASYMADE TI is a patient-specific titanium implant designed for reconstruction of cranial and non-load-bearing craniofacial defects. It is created from patient CT scan data and manufactured using laser powder bed fusion (LPBF) additive manufacturing. The device is supplied non-sterile and requires user-performed steam sterilization before surgical implantation.

The device is fabricated from Ti-6Al-4V ELI (Grade 23) titanium alloy conforming to ASTM F136 and ASTM F3001. It employs LPBF additive manufacturing, while predicates used CNC milling or electrobeam methods. EASYMADE TI offers mesh or solid configurations; the primary predicate (Meticuly) offers mesh only. It has a dimensional range of 10–150 mm length/width and 1.5–35 mm height with pore size of 750–950 μm for mesh variants.

ASTM F136 and ASTM F3001 for titanium material specifications. ISO 13485 clauses cited for design controls (7.3), nonconforming product handling (8.3), corrective action (8.5.2), and preventative action (8.5.3). Testing also included mechanical performance, biocompatibility evaluation, and software verification.

EASYMADE TI shares the same product code (GXN), classification (Class II), regulation (21 CFR 882.5330), and intended use as predicate devices including Meticuly (K210099), BioArchitects (K151692), and MedCAD (K220357). Non-clinical testing demonstrated equivalent mechanical performance, biocompatibility, and software functionality. Differences in manufacturing process and design structure are supported by validated testing and do not affect safety or effectiveness.