Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Internal Fixation Systems, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113399 | IFS SUBTALAR IMPLANT | Internal Fixation Systems, Inc. | 2011-12-20 | 33 | 0 |
| K110086 | IFS PROFILE PLATES, SCREWS, AND WASHERS | Internal Fixation Systems, Inc. | 2011-09-09 | 240 | 0 |
| K071035 | IFS BONE FIXATION DEVICES | Internal Fixation Systems, Inc. | 2007-08-13 | 123 | 0 |
| K061620 | IFS CANNULATED BONE SCREW | Internal Fixation Systems, Inc. | 2006-07-26 | 47 | 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