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The paste made with the ProFusion® Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. ProFusion® paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process. ProFusion® Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocompatible, they may be used at an infected site.

ProFusion® Bone Graft Substitute Kits consist of pre-measured medical grade calcium sulfate powder and pre-measured mixing solution, and the tools necessary to mix the components into a paste. The device is provided sterile for single use only. When its components are mixed according to the instructions, the ProFusion Kits produce biodegradable, radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling. After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). These bone voids or gaps may be either surgically created or result from traumatic injury. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

The ProFusion™ implants are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The implant is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bony cavities may be surgically created or the result of traumatic injury. The implant provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Because the implant is biodegradable and biocompatible, it may be used at an infected site.

ProFusion™ implants are made of medical grade caloium suffate and stearic acid (as processing aid). They are provided sterile for single use. The implants are non-pyrogenic, biodegradable, radiopaque and resorbed in approximately 30-60 days, when used according to labeling.