# K202475: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical GmbH
- Decided: Nov 23, 2020 after 87 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: 3 generations back to P810020 (1984). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030902: Palacos R, Heraeus Kulzer GmbH & Co. KG (2003) Summary page 9.
- K150119: PALACOS R pro, Heraeus Medical GmbH (2015) Summary page 9.
- K031673: Refobacin -Palacos G, Heraeus Kulzer GmbH & Co. KG (2004) Summary page 9.
- K142157: Palacos R+G Pro, Heraeus Medical GmbH (2014) Summary page 9.
- K050855: Palamed G, Heraeus Kulzer,GmbH (2005) Summary page 9.

## Most influential descendants
- K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (2021), 1 descendant of its own
- K211869: OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (2022), 0 descendants of its own
- K213812: PALACOS MV pro (2022), 0 descendants of its own

## Indications for use
PALACOS® R is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. PALACOS® R pro is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. PALACOS® R+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. PALACOS® R+G pro is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. PALACOS® MV+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/K202475
Methodology: https://510kreport.com/methodology