# K173494: OrthoSteady G Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: G21, S.R.L.
- Decided: Mar 6, 2018 after 113 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: 5 generations back to P810020 (1984). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031673: Refobacin -Palacos G, Heraeus Kulzer GmbH & Co. KG (2004) Summary page 4.
- K053002: Depuy CMW 1 Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2005) Summary page 4.

## Most influential descendants
- K193061: G3 40 Radiopaque Bone Cement (2020), 0 descendants of its own
- K193059: G1 40 Radiopaque Bone Cement (2020), 0 descendants of its own

## Indications for use
OrthoSteady G Bone Cement 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/K173494
Methodology: https://510kreport.com/methodology