510(k) Report

FDA applicant

G21, S.R.L.

San Possidonio, IT12 decisions2015–20250 recalls

FDA records 12 decisions for G21, S.R.L. (San Possidonio, IT) from 2015 to 2025: 12 510(k) clearances. Most are in product codes MBB (Bone Cement, Antibiotic) and LOD (Bone Cement). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 139 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided G21, S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12016: 12018: 12019: 32020: 32021: 12023: 12025: 1
2015high 3 (2019) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — G21, S.R.L. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBBBone Cement, Antibiotic5decisions
  • LODBone Cement5decisions
  • NDNCement, Bone, Vertebroplasty1decision
  • KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 154 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 139 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 26 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173494OrthoSteady G Bone CementG21, S.R.L. · 20182cite it
  • K190216SpaceFlex KneeG21, S.R.L. · 20191cites it
  • K150408V-Steady, V-FastG21, S.R.L. · 20151cites it
  • K152557Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 20161cites it
  • K202338SpaceFlex ShoulderG21, S.R.L. · 20211cites it

What has FDA decided for it lately?

  • K252443SpaceFix Shoulder SpacerG21, S.R.L. · 2025
  • K223441SpaceFlex Acetabular CupG21, S.R.L. · 2023
  • K202338SpaceFlex ShoulderG21, S.R.L. · 2021
  • K201960SpaceFlex Knee - 80mm SizeG21, S.R.L. · 2020
  • K193061G3 40 Radiopaque Bone CementG21, S.R.L. · 2020
  • K193059G1 40 Radiopaque Bone CementG21, S.R.L. · 2020
  • K192041G21 SpaceFlex HipG21, S.R.L. · 2019
  • K190216SpaceFlex KneeG21, S.R.L. · 2019

All 12 as G21, S.R.L. →