# K030902: Palacos R

- Pathway: 510(k) (Abbreviated)
- Applicant: Heraeus Kulzer GmbH & Co. KG
- Decided: Sep 23, 2003 after 183 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
Longest line of descent: 1 generation back to P810020 (1984). 1 ancestor in all.
13 later devices descend from it; 9 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P810020: Palacos R Bone Cement, Smith & Nephew Richards, Inc. (1984) Summary page 1.

## Most influential descendants
- K150119: PALACOS R pro (2015), 4 descendants of its own
- K202475: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G (2020), 3 descendants of its own
- K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (2021), 1 descendant of its own
- K053198: Simplex P Speedset Bone Cement (2006), 1 descendant of its own
- K211869: OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (2022), 0 descendants of its own

## Indications for use
Palacos® R is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Source page: https://510kreport.com/device/K030902
Methodology: https://510kreport.com/methodology