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OrthoSteady G Bone Cement

by G21 S.R.L. Italy 510(k)

510(k) K173494

Product code LOD

Overview

OrthoSteady G Bone Cement is a self-curing, radiopaque, polymethyl methacrylate based bone cement. It is used for securing metal or polymeric prostheses to living bone in arthroplasty revision procedures, including hip, knee, ankle, and shoulder joint replacements.

This device is a standard viscosity cement intended for manual application. It is supplied as a sterile product and has received FDA 510(k) clearance.

Summary written by AI from registry data, 21 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173494 Date6 Mar 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
LOD
FDA applicant
G21, S.R.L.
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

From the manufacturer

G1™ and OrthoSteady G bone cements are a standard viscosity cement, primarily intended for manual application. The G1™ sterile radiopaque bone cements have a consistency and working time particularly suitable for cementation of knee prostheses.

Source: g-21.it

Orthopedic - Bone cements - The G21 bone cements for orthopedics are the results of the evaluation and improvement of the other systems available on the market; they are designed and manufactured to minimize the impact on their mechanical properties of factors such as ambient conditions and preparation methods.

Source: g-21.it

Other devices from G21 S.R.L.

See all devices from G21 S.R.L. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K173494 24 fields · synced 22 Oct 2026