# P810020: Palacos R Bone Cement

- Pathway: PMA
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Feb 2, 1984 after 995 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
104 later devices descend from it; 9 cite it directly.
0 of 105 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
- K030903: Osteopal (2003), 40 descendants of its own
- K050085: Osteopal V (2005), 38 descendants of its own
- K150408: V-Steady, V-Fast (2015), 28 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- K030086: Palacos R Bone Cement with Gentamicin (2003), 25 descendants of its own

## Recalls of this device
- Jan 17, 2003 · Not classified · Z-0546-03: There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.

Source page: https://510kreport.com/device/P810020
Methodology: https://510kreport.com/methodology