Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PQC · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
193 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | 2026-02-25 | 138 | 0 |
| K231483 | MySpine Unilateral Guides | Medacta International S.A. | 2023-07-21 | 59 | 0 |
| K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Lo | Medacta International S.A. | 2021-04-06 | 111 | 0 |
| K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | Medacta Inernational SA | 2020-10-05 | 193 | 0 |
| K181883 | FIREFLY® Midline Navigation Guide | Mighty Oak Medical, Inc. | 2018-10-03 | 82 | 0 |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018-07-24 | 56 | 0 |
| K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot | Medacta International S.A. | 2018-04-19 | 161 | 0 |
| K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016-10-28 | 59 | 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