# K061131: DBX-H Hemostatic Demineralized Bone Matrix Putty

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Feb 8, 2007 after 290 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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.
- K051195: Grafton DBM, Osteotech, Inc. (2005) Summary page 1.

## Indications for use
DBX-HTM Hemostatic Demineralized Bone Matrix Putty is indicated for use for filling voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. DBX-HTM can help control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used for treatment of surgically created osseous defects and in osseous defects resulting from traumatic injury.

Source page: https://510kreport.com/device/K061131
Methodology: https://510kreport.com/methodology