The US Food and Drug Administration (FDA) has granted additional clearances for a resorbable bone putty made by Abryx. The putty can be used as both a bone void filler and cranial bone cement.
Previously FDA-cleared on bleeding bone, the Connecticut, US-based biomaterial sciences company say that the putty, named Montage Settable, can achieve bone-like properties within minutes of mixing and application.
“These expanded clearances for Montage reflect its versatility, which is derived from its unique, self-setting, and absorbable polymer. The product already has an impressive track record, with more than 22,000 uses since its initial FDA clearance, and we expect that these latest clearances will support its expanded use across more applications,” said John J. Pacifico, founding president and chief executive officer of Abyrx.
The putty, which is designed to resorb during bone remodeling processes and eventually replaced by the bone, is expected to be used by surgeons across a range of specialties. Unlike traditional settable calcium phosphate products (which can be brittle), Montage contains a proprietary polymer that allows for moulding and shaping during the hardening process.
The product can be used to stabilise bone fragments and primary fixation hardware constructs during the procedure. It can also be drilled and tapped, and hardware can be placed through it at any time during the setting process.
In 2021, GlobalData estimated the bone graft and substitutes market to be $2.8bn in 2021. The increase in the global aging population is a long-term trend and is expected to result more procedures for orthopedic injury and diseases.