# K110976: Origen DBM with Bioactive Glass, Nanofuse DBM

- Pathway: 510(k) (Special)
- Applicant: Nanotherapeutics, Inc.
- Decided: May 3, 2011 after 26 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960978 (1996). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062459: Origen DBM with Bioactive Glass, Nanotherapeutics (2007) Summary page 1.

## Most influential descendants
- K120279: Nanofuse DBM (2012), 2 descendants of its own
- K142104: Nanofuse DBM (2015), 1 descendant of its own
- K161996: 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE (2017), 0 descendants of its own

## Recalls of this device
- Mar 10, 2011 · Not classified · Z-0347-2012: On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distribu
- Mar 10, 2011 · Not classified · Z-0346-2012: On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distribu

## Indications for use
Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Source page: https://510kreport.com/device/K110976
Methodology: https://510kreport.com/methodology