# K042730: Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5G/1.0G

- Pathway: 510(k) (Traditional)
- Applicant: Lifecorebiomedical
- Decided: Feb 14, 2005 after 136 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943186 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943186: Capset Calcium Sulfate Bone Graft Plaster, Lifecore Biomedical, Inc. (1995) Summary page 1.

## Indications for use
When mixed to the proper consistency using the pre-measured mixing solution supplied in each package, CalForma Calcium Sulfate Bone Graft Barrier can be formed over bony defects. When used over a bone graft, CalForma provides a stable barrier to graft material migration.

Source page: https://510kreport.com/device/K042730
Methodology: https://510kreport.com/methodology