Abyrx Gains Additional FDA Clearances for MONTAGE Bone Putty

Abyrx received FDA 510(k) clearances to market the company’s MONTAGE Settable, Resorbable Bone Putty as both a bone void filler and cranial bone cement. MONTAGE is a hand-moldable, hardening putty that provides intraoperative utility and achieves bone-like properties within minutes of mixing and application.

MONTAGE offers an alternative to traditional settable calcium phosphate/sulfate and magnesium-based products, which tend to be brittle. The hardening component of MONTAGE comprises a proprietary polymer that allows the product to be moldable and shapeable during the hardening process and machined using standard tools found in operating rooms. Following surgery, MONTAGE is designed to resorb during the bone remodeling process and be replaced by bone. Due to the fact that MONTAGE is cohesive, adheres to bone and hardens, it may be used to help stabilize bone fragments and primary fixation hardware constructs during the procedure. The product can also be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Building upon MONTAGE’s success, the company has introduced MONTAGE FastSet, which reduces the product’s hardening time by approximately 50%; MONTAGE XT, which doubles the product’s hardening time; MONTAGE FLOWABLE, which is offered in a hand-held delivery system with a static mix tip to enhance its ease-of-use, and PERMATAGE, a non-absorbable settable putty. Additional development efforts of its proprietary technology platform are underway for tissue fixation, intra-operative shaping of patient-specific implant devices, and site-specific delivery of growth factors, anti-infective agents, and local anesthetic drugs.

Source: Abyrx