Meticuly Announces FDA 510(k) Clearance for Patient-Specific Titanium Maxillofacial Mesh Implant

Our METICULY Patient-Specific Titanium Maxillofacial Mesh Implant has received US Food and Drug Administration (FDA) 510(k) clearance! This follows the success of our METICULY Patient-Specific Titanium Mesh Implant for cranioplasty that was cleared in 2021 and recently entered the U.S. market.

The Maxillofacial implant is engineered to address the intricate reconstructive challenges of the facial and orbital areas that standard size implants cannot overcome. By integrating proprietary Laser Powder Bed Fusion manufacturing technique with meticulous pre-operative planning, personalization, and a low-profile mesh design, we ensure seamless surgical procedures while preserving the natural facial aesthetics of our patients.

With this second FDA clearance, we broaden Meticuly’s product range to deliver comprehensive cranio-maxillofacial customized solutions. We are dedicated to further expanding our portfolio and reinforcing our position at the forefront of personalized healthcare solutions.

Reference: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232889