# P960001: Depuy 1 Bone Cement

- Pathway: PMA
- Applicant: Depuy, Inc.
- Decided: Feb 11, 1997 after 397 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K033382: Smartset GMV Endurance Gentamicin Bone Cement (2004), 16 descendants of its own
- K023012: Smartset HV Bone Cement (2003), 12 descendants of its own
- K033563: Smartset GHV Gentamicin Bone Cement (2004), 9 descendants of its own
- K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement (2004), 8 descendants of its own
- K053002: Depuy CMW 1 Gentamicin Bone Cement (2005), 4 descendants of its own

Source page: https://510kreport.com/device/P960001
Methodology: https://510kreport.com/methodology