# K001724: Stimulan -Calcium Sulfate Bone Void Filter

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Aug 4, 2000 after 59 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Stimulan TM is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Siimulan TM is manufactured from medical grade calcium sulfate that res,orbsand is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at An infected site.

Source page: https://510kreport.com/device/K001724
Methodology: https://510kreport.com/methodology