# K011403: Surgiplaster Calcium Sulfate Hemihydrate

- Pathway: 510(k) (Traditional)
- Applicant: Orthogen Corp.
- Decided: Sep 11, 2001 after 127 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
No predicates in its family tree.
3 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060285: Bonegen - TR (2006), 1 descendant of its own
- K102208: Nanogen (2011), 0 descendants of its own
- K051381: Ace Surgicalplaster Calcium Sulface Hemihydrate (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K011403
Methodology: https://510kreport.com/methodology