# K210193: DB-Composite

- Pathway: 510(k) (Traditional)
- Applicant: Dimensional Bioceramics, LLC
- Decided: Mar 15, 2021 after 49 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: 4 generations back to K011897 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112383: Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void Filler, Skeletal Kinetics, LLC (2012) Summary page 4.

## Indications for use
DB-Composite Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K210193
Methodology: https://510kreport.com/methodology