# K051381: Ace Surgicalplaster Calcium Sulface Hemihydrate

- Pathway: 510(k) (Traditional)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: Jul 15, 2005 after 49 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011403 (2001). 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)
- K011403: Surgiplaster Calcium Sulfate Hemihydrate, Orthogen Corp. (2001) Summary page 1.

## Recalls of this device
- May 14, 2010 · Not classified · Z-1805-2010: Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not a
- May 14, 2010 · Not classified · Z-1806-2010: Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not a

## Indications for use
The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and, to provide a resorbable barrier over other bone graft material.

Source page: https://510kreport.com/device/K051381
Methodology: https://510kreport.com/methodology