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VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold® and deliver the material to the orthopaedic surgical site.

The Vitoss-Filled Cartridge is a device that combines two Orthovita products, Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe II Syringe (K030208) into a kit configuration. The convenience kit provides the Imbibe II Syringe loaded (filled) with Vitoss Scaffold and an empty 30cc secondary syringe (Merit Piston Syringe. K875196). An adapter valve, which can be connected to the vacuum line in the surgical suite, is also provided. The surgeon can use either the secondary syringe or the vacuum line adapter to aspirate blood or marrow into the Vitoss-Filled Cartridge.

The provided text describes a 510(k) submission for the Orthovita Vitoss-Filled Cartridge, which is a combination of two existing products: Vitoss Scaffold bone void filler and the Imbibe II Syringe.

However, the document does not contain any information about a study proving the device meets specific acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on the combination of existing cleared components without changes to their individual designs. Therefore, a table of acceptance criteria and reported device performance cannot be generated from this text, nor can other study-specific details.

The 510(k) summary explicitly states: "No changes have been made to the Vitoss Scaffold or the Imbibe II Syringe." This indicates that the regulatory approval is based on the established safety and efficacy of the individual components and their combination into a convenience kit, rather than on new performance studies for the combined product.

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