# K103173: Vitoss BA Bimodal Bioactive Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Orthovita, Inc.
- Decided: Feb 7, 2011 after 102 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: 7 generations back to K960978 (1996). 31 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 49 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 1.
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 1.
- K041613: Novabone - AR - Resorbable Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 1.

## Most influential descendants
- K130392: Kinex Bioactive (2013), 8 descendants of its own
- K173008: SCS 17-01 (2017), 4 descendants of its own
- K190956: SCS 17-01 (2020), 3 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K163621: Vitoss Bioactive (BA) Injectable (2017), 2 descendants of its own

## Indications for use
Vitoss BA Bimodal Bioactive Bone Graft Substitute 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 Bimodal is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss BA Bimodal Bioactive Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), 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/K103173
Methodology: https://510kreport.com/methodology