Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genesis Fracture Care, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
174 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171293 | G3™ Active Plate® Miniature System | Genesis Fracture Care, Inc. | 2017-10-23 | 174 | 0 |
| K160633 | G3(TM) Active Plate(R) Small Fragment System | Genesis Fracture Care, Inc. | 2016-04-22 | 46 | 0 |
| K152242 | G3¿ Active Plate® Large Fragment System | Genesis Fracture Care, Inc. | 2015-11-24 | 106 | 0 |
| K150649 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | 2015-04-30 | 49 | 0 |
| K142938 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | 2014-11-26 | 48 | 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