Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute

Vitoss Bone Graft Substitute is a resorbable calcium salt device intended for use as a bone void filler in the skeletal system (extremities, pelvis, spine including intervertebral disc space and posterolateral fusion). It is indicated for surgically created osseous defects or defects from traumatic bone injury, and can be combined with saline, autogenous blood, and/or bone marrow. The scaffold resorbs and is replaced with bone during healing.

The subject devices have the same intended use, design, materials, operating principles, and performance specifications as their respective predicates. The modification expands indications to include pediatric patients ≥6 years old and use of previously cleared FDA cages. There is no physical change to the products from this labeling change.

Not stated in this summary.

The devices are substantially equivalent because they have identical intended use, design, materials, operating principles, and performance specifications as their predicates (K242280 primary). The expanded indications for pediatric patients and intervertebral body fusion with FDA-cleared cages do not introduce new or significantly changed risks and are supported by clinical and performance testing rationale. No new testing was performed as the indications expansion does not impact safety and efficacy.