Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dunamis, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
160 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193245 | Dunamis PunchTac Suture Anchors | Dunamis, LLC | 2020-02-14 | 81 | 0 |
| K191319 | Dunamis Fixation Button System | Dunamis, LLC | 2019-08-29 | 106 | 0 |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | Dunamis, LLC | 2016-07-06 | 89 | 0 |
| K153746 | Dunamis Force DFX Tensile Tape | Dunamis, LLC | 2016-03-03 | 65 | 0 |
| K151220 | Dunamis Interference Screw | Dunamis, LLC | 2015-10-14 | 160 | 0 |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture S | Dunamis, LLC | 2015-06-29 | 139 | 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