# K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical GmbH
- Decided: Jul 9, 2021 after 130 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P810020 (1984). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202475: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G, Heraeus Medical GmbH (2020) Summary page 7.

## Most influential descendants
- K213812: PALACOS MV pro (2022), 0 descendants of its own

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3302-2026: Potential for monomer liquid leakage.
- Aug 20, 2026 · Class II · Z-3301-2026: Potential for monomer liquid leakage.
- Aug 20, 2026 · Class II · Z-3303-2026: Potential for monomer liquid leakage.
- Dec 9, 2025 · Class II · Z-1081-2026: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortun
- Dec 9, 2025 · Class II · Z-1082-2026: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortun
- Dec 9, 2025 · Class II · Z-1080-2026: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortun

## Indications for use
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 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 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.

Source page: https://510kreport.com/device/K210607
Methodology: https://510kreport.com/methodology