
Dimension Inx announced that CMFlex, the first FDA-cleared 3D-printed regenerative bone graft product, has been successfully used in its first clinical cases.
Procedures performed included a mandibular angle augmentation and maxillary segmental osteotomy.
CMFlex is a 3D-printed synthetic bone graft used for various bony defects in oral and maxillofacial surgical applications. CMFlex utilizes a chemistry comprised primarily of hydroxyapatite particles combined with biodegradable polylactide-co-glycolide polymer. Both materials have an extensive history demonstrating biocompatibility and clinical utility.
Dimension Inx combines these base materials into a proprietary, microstructurally porous composite material, Hyperelastic Bone. This unique, easily deployable bone repair material is then 3D-printed into CMFlex. The resulting product is one that surgeons can size for each patient and is uniquely capable of absorbing fluid, which enables it to control bleeding during surgery while assisting the bone remodeling process once implanted.
Dimension Inx received FDA clearance of CMFlex in December 2022. CMFlex is currently available to a limited number of key surgeons with a broader release to follow later in 2024.
Source: Dimension Inx
JAV
Julie A. Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.