# K021551: Stimulan - Calcium Sulfate Bone Void Filler Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Nov 1, 2002 after 172 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K141830: Stimulan Kit, Stimulan Rapid Cure (2015), 2 descendants of its own
- K250141: Synthecure Synthetic Calcium Sulfate (2025), 0 descendants of its own
- K171161: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) (2017), 0 descendants of its own
- K040600: Genex Bone Graft Substitute (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K021551
Methodology: https://510kreport.com/methodology