Moldable Bone Void Filler and Moldable Bone Void Filler + CCC

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are bone void fillers designed to fill bony voids or gaps in the skeletal system (extremities and pelvis) resulting from surgical creation or traumatic injury. The devices are composed of processed demineralized bone matrix, synthetic macromer hydrogel, and cortical cancellous bone chips (in the +CCC variant), and gradually resorb while being replaced with new bone during healing.

The devices are composed of processed demineralized bone matrix (DBM), a synthetic macromer hydrogel, and cortical cancellous bone chips (CCC) for the +CCC variant only. Both versions are provided with an accessory kit containing pre-measured hydrating solution and a spatula. The devices are moldable putties that are hydrated, handled, and placed into bone defects.

Not stated in this summary. The document references compliance with the 'Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device' but does not cite specific ISO, IEC, or ASTM consensus standards.

The devices have the same intended use as the predicate (Exactech Optecure and Optecure + CCC, K121989) for filling skeletal bone voids. Although there are differences in technological characteristics, non-clinical testing data—including chemical/physical properties, biocompatibility, sterility, shelf life, and animal studies showing comparable new bone formation (16.21% for Optecure vs. 15.75% for predicate at 12 weeks)—demonstrate that these differences do not raise safety or effectiveness concerns relative to the predicate device.