Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iconn Orthopedics, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
268 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180670 | ICONN Campbell Interference Screw | Iconn Orthopedics, LLC | 2018-12-07 | 268 | 0 |
| K182264 | ICONN Revolution Knotless Suture Anchor | Iconn Orthopedics, LLC | 2018-10-19 | 59 | 0 |
| K181680 | ICONN Answer II Suture Anchor | Iconn Orthopedics, LLC | 2018-08-09 | 44 | 0 |
| K172491 | ICONN Square 2.5MM Suture Anchor | Iconn Orthopedics, LLC | 2017-11-29 | 104 | 0 |
| K132724 | ICONN ANSWER SUTURE ANCHOR | Iconn Orthopedics, LLC | 2014-04-17 | 230 | 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