Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iconacy Orthopedic Implants, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
152 daysmedian FDA review time
284 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160266 | ICONACY(TM) I-Hip(TM) | Iconacy Orthopedic Implants, LLC | 2016-04-08 | 66 | 0 |
| K151307 | ICONACY(TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | 2016-02-26 | 284 | 0 |
| K132572 | I-HIP TOTAL HIP SYSTEM | Iconacy Orthopedic Implants, LLC | 2014-03-28 | 225 | 0 |
| K133228 | ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYS | Iconacy Orthopedic Implants, LLC | 2014-01-17 | 88 | 0 |
| K131279 | ICONACY I-HIP SYSTEM | Iconacy Orthopedic Implants, LLC | 2013-08-09 | 95 | 0 |
| K121034 | IOI TOTAL HIP | Iconacy Orthopedic Implants, LLC | 2012-09-04 | 152 | 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