# K062459: Origen DBM with Bioactive Glass

- Pathway: 510(k) (Traditional)
- Applicant: Nanotherapeutics
- Decided: Feb 26, 2007 after 187 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: 3 generations back to K960978 (1996). 5 ancestors in all.
56 later devices descend from it; 3 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021336: Novabone-Resorbable Bone Graft Substitute, Novabone Products, LLC (2002) Summary page 1.
- K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste, Regeneration Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K072184: Vitoss Bioactive Foam Bone Graft Substitute (2007), 51 descendants of its own
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute (2008), 50 descendants of its own
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute (2008), 47 descendants of its own
- K090855: Equivabone Osteoinductive Bone Graft Substitute (2009), 25 descendants of its own
- K091607: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone (2009), 22 descendants of its own

## Indications for use
Origen DBM with Bioactive Glass is indicated for bony voids or gaps 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 system (e.g., the 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 graft substitute that remodels into the recipient's skeletal system.

Source page: https://510kreport.com/device/K062459
Methodology: https://510kreport.com/methodology