Silicone-block tissue reconstructive material

This category consists of solid, non-sterile blocks made from silicone elastomer that are shaped by the surgeon during a procedure to reconstruct or augment soft tissue or bone. These blocks are customized to fit individual patient anatomy and are implanted after sterilization to support reconstructive or cosmetic plastic surgery, such as chin, malar, gluteal, or calf augmentation.

As a single-use device, each block is intended for one procedure only and is supplied in a non-sterile state, requiring sterilization by the healthcare provider before implantation. Regulation of these devices focuses on their material composition, sterility process, and intended use in surgical reconstruction, with classification determined by jurisdiction based on risk and invasiveness.