# K031673: Refobacin -Palacos G

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer GmbH & Co. KG
- Decided: May 25, 2004 after 361 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
Longest line of descent: 1 generation back to P810020 (1984). 1 ancestor in all.
15 later devices descend from it; 9 cite it directly.
0 of 17 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
- K142157: Palacos R+G Pro (2014), 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
- K173494: OrthoSteady G Bone Cement (2018), 2 descendants of its own
- K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (2021), 1 descendant of its own
- K171540: Refobacin Bone Cement R (2017), 1 descendant of its own

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0730-2014: The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

## Indications for use
PALACOS G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Source page: https://510kreport.com/device/K031673
Methodology: https://510kreport.com/methodology