# K171161: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

- Pathway: 510(k) (Traditional)
- Applicant: Dimensional Bioceramics, LLC
- Decided: Sep 25, 2017 after 158 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: 2 generations back to K021551 (2002). 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)
- K141830: Stimulan Kit, Stimulan Rapid Cure, Biocomposites, Ltd. (2015) Summary page 4.

## Indications for use
Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and biocompatible and may be used in an infected site.

Source page: https://510kreport.com/device/K171161
Methodology: https://510kreport.com/methodology