# K250141: Synthecure Synthetic Calcium Sulfate

- Pathway: 510(k) (Traditional)
- Applicant: Austin Medical Ventures, Inc.
- Decided: May 16, 2025 after 119 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 6.

## Indications for use
Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process. Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.

Source page: https://510kreport.com/device/K250141
Methodology: https://510kreport.com/methodology