# K003493: 3I Calcium Sodium Phosphate Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 9, 2001 after 88 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K040501: DBX Demineralized Bone Matrix Putty, Paste and Mix (2005), 3 descendants of its own
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K081950: Progenix Plus (2008), 1 descendant of its own
- K082463: Progenix (2008), 0 descendants of its own
- K033611: Calcigen -Nap Bone Void Filler (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K003493
Methodology: https://510kreport.com/methodology