Synthecure Synthetic Calcium Sulfate

Synthecure Synthetic Calcium Sulfate is a sterile, single-use bone void filler implant designed to fill bony voids or gaps in the skeletal system (extremities and pelvis) resulting from surgical or traumatic injury. The device consists of calcium sulfate powder mixed with a solution to form a paste that can be packed directly into bone defects or molded into beads, which resorb and are replaced by bone over approximately 30-60 days. It is biocompatible, biodegradable, and may be used at infected sites.

Synthecure is presented as a powder manufactured from medical-grade calcium sulfate combined with a mixing solution that forms a paste when mixed, matching the predicate devices' format and composition. Both the subject device and predicates are designed to be implanted into non-structural bone defects, are biocompatible, resorbable, and support bone healing through gradual replacement. The chemical composition and physical properties were evaluated and demonstrated equivalent to the predicates, with similar working and setting times confirmed through aging studies.

ISO 10993-1 (biocompatibility evaluation), ANSI/AAMI ST72:2011 (bacterial endotoxin testing), ISO 11607-1:2019 and ISO 11607-2:2019 (packaging validation), and FDA Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices (June 2, 2003).

The device is substantially equivalent because it shares identical intended use (filling non-structural bone defects), similar design and materials (medical-grade calcium sulfate powder with mixing solution), and equivalent technological characteristics with the predicates. Bench testing confirmed equivalent chemical composition and physical properties; animal implantation studies in rabbits demonstrated comparable biocompatibility and resorption kinetics; and all safety testing (sterilization, endotoxin, biocompatibility) met recognized standards, demonstrating no new safety or effectiveness concerns compared to predicate devices.