Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Implanet, S.A. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
132 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230026 | SQUALE | Implanet, S.A. | 2023-03-28 | 83 | 0 |
| K192084 | Madison Total Knee System | Implanet, S.A. | 2019-10-22 | 81 | 0 |
| K191217 | JAZZ PF | Implanet, S.A. | 2019-08-02 | 88 | 0 |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Implanet, S.A. | 2019-03-12 | 165 | 0 |
| K171881 | JAZZ Passer Band | Implanet, S.A. | 2017-08-08 | 46 | 0 |
| K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017-06-09 | 92 | 0 |
| K162764 | JAZZ FRAME SYSTEM | Implanet, S.A. | 2017-01-19 | 111 | 0 |
| K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector | Implanet, S.A. | 2016-05-18 | 110 | 0 |
| K153348 | JAZZ LOCK | Implanet, S.A. | 2016-03-31 | 132 | 0 |
| K151740 | JAZZ System | Implanet, S.A. | 2015-08-27 | 62 | 0 |
| K143759 | JAZZ System | Implanet, S.A. | 2015-05-07 | 127 | 0 |
| K143731 | IMPLANET Spine System (ISS) | Implanet, S.A. | 2015-04-14 | 106 | 0 |
| K133617 | JAZZ SYSTEM | Implanet, S.A. | 2014-02-20 | 87 | 0 |
| K132303 | IMPLANET SPINE SYSTEM | Implanet, S.A. | 2013-10-10 | 78 | 0 |
| K121541 | JAZZ SYSTEM | Implanet, S.A. | 2012-09-13 | 112 | 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