# K163621: Vitoss Bioactive (BA) Injectable

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: May 2, 2017 after 131 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K960978 (1996). 62 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 4.
- K103173: Vitoss BA Bimodal Bioactive Bone Graft Substitute, Orthovita, Inc. (2011) Summary page 4.
- K141600: Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit, Pioneer Surgical Technology, Inc. (Rti Surgical, I (2014) Summary page 4.
- K132868: Carricell, Etex Corporation (2015) Summary page 4.

## Most influential descendants
- K242797: OsteoFlo HydroFiber (2024), 1 descendant of its own
- K243949: OsteoFlo HydroFiber (2025), 0 descendants of its own

## Indications for use
Vitoss BA Injectable 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 BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K163621
Methodology: https://510kreport.com/methodology