# K091218: DBX Demineralized Bone Matrix Putty

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Sep 28, 2009 after 154 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K080405: Sygnal DBM, Musculoskeletal Transplant Foundation (2008) Summary page 1.

## Indications for use
DBX® Inject 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 as follows: Indications for Use: Extremities; Posterolateral spine; Pelvis DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

Source page: https://510kreport.com/device/K091218
Methodology: https://510kreport.com/methodology