# K142463: Bio2 CLM BG Bioactive Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Bio2 Technologies, Inc.
- Decided: Dec 18, 2014 after 107 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.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101860: Novabone Putty- Bioactive Synthetic Bone Graft, Novabone Products, LLC (2010) Summary page 4.
- K090177: Inion Biorestore Biodegradable Bone Graft Substitute, Inion OY (2009) Summary page 4.
- K033707: Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX, Osteobiologics, Inc. (2004) Summary page 4.
- K013072: Chronos Tricalcium Prosphate (Chronos TCP), Synthes (2002) Summary page 4.

## Most influential descendants
- K151876: Bio2 Fusion Implant System (2015), 0 descendants of its own

## Indications for use
The Bio2 CLM+BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bio2 CLMsBG Bioactive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osscous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K142463
Methodology: https://510kreport.com/methodology