# K193061: G3 40 Radiopaque Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: G21, S.R.L.
- Decided: Mar 19, 2020 after 139 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: 6 generations back to P810020 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 4.
- K173494: OrthoSteady G Bone Cement, G21, S.R.L. (2018) Summary page 4.

## Indications for use
G3 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Source page: https://510kreport.com/device/K193061
Methodology: https://510kreport.com/methodology