# K063676: DBX Demineralized Bone Matrix Mix

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Mar 5, 2007 after 84 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K091193: Accell EVO3C (2009), 2 descendants of its own
- K212135: Dry DBM- A Putty (2021), 1 descendant of its own
- 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
- K231030: Cove Putty, OsteoCove Putty (2023), 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: Putty: Extremities, Pelvis, Posterolateral Spine, Cranium Mix: Extremities, Pelvis, Spine Paste: Extremities 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 autograft. DBX®Mix may be used as a bone void filler in the spine. DBX® can be used with bone marrow. DBX® is for single patient use only.

Source page: https://510kreport.com/device/K063676
Methodology: https://510kreport.com/methodology