T/CAMDI 115-2023 Active

Main technical content: This document specifies the terms and definitions, expected performance, design attributes, requirements, test methods, manufacturing, cleaning, sterilization, packaging, and manufacturer-provided information for additive manufactured biomechanical adaptive intervertebral fusion devices. This document applies to biomechanical adaptive intervertebral fusion devices manufactured by additive manufacturing methods for placement in the intervertebral disc position to provide mechanical support for intervertebral fusion. This document applies to TC4 or TC4 ELI material intervertebral fusion devices manufactured by powder bed fusion additive manufacturing using electron beams or lasers as energy sources. Intervertebral fusion devices manufactured by other additive manufacturing processes and/or materials can refer to the applicable content of this document.