# K053218: DBX Demineralized Bone Matrix Putty/Paste/Mix

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Dec 28, 2006 after 406 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: 1 generation back to K040262 (2005). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040262: DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix, Musculoskeletal Transplant Foundation (2005) Summary page 2.

## Most influential descendants
- K121989: Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone Void Filler (1CC, 2CC, 5CC, 10CC, (2012), 1 descendant of its own
- K241555: Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (2025), 0 descendants of its own

## Indications for use
DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the: Paste and Mix: Extremities, Pelvis Putty: Extremities, Pelvis, Posterolateral spine, Cranium DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autografi. DBX® can be used with bone marrow. DBX® is for single patient use only.

Source page: https://510kreport.com/device/K053218
Methodology: https://510kreport.com/methodology