# K141830: Stimulan Kit, Stimulan Rapid Cure

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Jan 23, 2015 after 200 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021551 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021551: Stimulan - Calcium Sulfate Bone Void Filler Kit, Biocomposites, Ltd. (2002) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Nov 12, 2020 · Class II · Z-0638-2021: The product is mislabeled.

## Indications for use
Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be swrgically created or created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Kit/Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Kit/Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site. To fill a bone void or defect created by: « surgery * acyst * atumour * osteomyelitis « traumatic injury

Source page: https://510kreport.com/device/K141830
Methodology: https://510kreport.com/methodology