Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paragon 28 — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
269 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171715 | HammerTube System | Paragon 28 | 2018-03-05 | 269 | 0 |
| K172886 | Breakaway Screw System | Paragon 28 | 2017-12-20 | 90 | 0 |
| K170923 | JAWS(TM) Nitinol Staple System | Paragon 28 | 2017-07-24 | 117 | 0 |
| K162241 | TITAN 3-D™ Wedge System | Paragon 28 | 2017-04-03 | 236 | 1 |
| K153378 | Monster BITE Screw System | Paragon 28 | 2015-12-21 | 28 | 0 |
| K151418 | Monster Screw System | Paragon 28 | 2015-07-15 | 48 | 0 |
| K140397 | PARALOCK PLATING SYSTEM / TUFFNEK SCREW | Paragon 28 | 2014-04-17 | 58 | 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