# K213812: PALACOS MV pro

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical GmbH
- Decided: Feb 2, 2022 after 57 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to P810020 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210607: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro, Heraeus Medical GmbH (2021) Summary page 4.

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3304-2026: Potential for monomer liquid leakage.
- Dec 9, 2025 · Class II · Z-1083-2026: 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® MV 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.

Source page: https://510kreport.com/device/K213812
Methodology: https://510kreport.com/methodology