# K091217: DBX Demineralized Bone Matrix Putty

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Oct 2, 2009 after 158 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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.
1 later device descends 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 1.
- K080405: Sygnal DBM, Musculoskeletal Transplant Foundation (2008) Summary page 1.

## Most influential descendants
- K130235: Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty (2014), 0 descendants of its own

## 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 Putty Paste Ridge augmentation Filling of extraction sites Craniofacial augmentation Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling resection defects in benign tumors, benign cysts, or other osseous defects in the alveolar ridge wall Filling of cystic defect Filling of lesions of periodontal origin Filling of defects of endodontic origin _/ _/ DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

Source page: https://510kreport.com/device/K091217
Methodology: https://510kreport.com/methodology