# K003954: Stimulan - Calcium Sulfate Bone Void Filler Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Jul 12, 2001 after 203 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.
5 later devices descend from it; 1 cites 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031319: Osteo-G Bone Void Filler System (2003), 4 descendants of its own
- K091688: A-Grix Resorbable Bone Void Filler (2010), 1 descendant of its own
- K121453: A-Grix TE Resorable Bone Void Filler (2013), 0 descendants of its own
- K072444: Wellgraft PE I (2008), 0 descendants of its own
- K072170: Wellgraft PE II (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K003954
Methodology: https://510kreport.com/methodology