# K152589: Bio2 CLM BG Bioactive Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Bio2 Technologies, Inc.
- Decided: Jan 12, 2016 after 124 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K071562: D3 Hematology Analyzer, Model D3, Drew Scientific, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K102653: Orion Drillable Bone Void Filler. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K088202: Orion Drillable Fast Set Putty. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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 osseous 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/K152589
Methodology: https://510kreport.com/methodology