Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Blue Ortho — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
293 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233299 | ExactechGPS® System | Blue Ortho | 2024-01-26 | 119 | 0 |
| K232521 | ExactechGPS® Total Ankle Application | Blue Ortho | 2023-11-16 | 90 | 0 |
| K213877 | ExactechGPS® System | Blue Ortho | 2022-05-02 | 140 | 0 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning So | Blue Ortho | 2022-01-06 | 59 | 1 |
| K193618 | ExactechGPS System | Blue Ortho | 2020-09-02 | 251 | 0 |
| K173372 | ExactechGPS Total Shoulder Application | Blue Ortho | 2017-11-24 | 28 | 1 |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning So | Blue Ortho | 2017-04-05 | 203 | 1 |
| K152764 | EXACTECH GPS | Blue Ortho | 2016-07-13 | 293 | 0 |
| K100742 | EXACTECH GPS | Blue Ortho | 2010-10-21 | 219 | 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