# K040262: DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Mar 17, 2005 after 407 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
No predicates in its family tree.
28 later devices descend from it; 13 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K060794: Progenix DBM Putty and Paste (2006), 9 descendants of its own
- K103784: DBX Demineralized Bone Matrix Putty (2011), 7 descendants of its own
- K103795: DBX Demineralized Bone Matrix Putty (2011), 6 descendants of its own
- K080399: DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix Paste (2008), 4 descendants of its own
- K072265: Progenix DMB Putty (2008), 4 descendants of its own

## Recalls of this device
- Sep 22, 2023 · Class II · Z-0323-2024: Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
- Dec 4, 2014 · Class II · Z-1455-2015: The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.

## Indications for use
DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

Source page: https://510kreport.com/device/K040262
Methodology: https://510kreport.com/methodology