Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
G21, S.R.L. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
239 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025-09-15 | 42 | 0 |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | 2023-03-23 | 129 | 0 |
| K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021-02-17 | 184 | 0 |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | 2020-08-13 | 30 | 0 |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 | 139 | 0 |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 | 139 | 0 |
| K192041 | G21 SpaceFlex Hip | G21, S.R.L. | 2019-10-29 | 90 | 0 |
| K190216 | SpaceFlex Knee | G21, S.R.L. | 2019-06-09 | 125 | 0 |
| K181282 | G3A 40 Bone Cement | G21, S.R.L. | 2019-01-09 | 239 | 0 |
| K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018-03-06 | 113 | 0 |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016-02-23 | 168 | 0 |
| K150408 | V-STEADY, V-FAST | G21, S.R.L. | 2015-12-14 | 299 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda