Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OSN · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | 2026-02-26 | 93 | 0 |
| K221792 | Acute QC Strut and Components | Smith & Nephew, Inc. | 2022-08-25 | 65 | 0 |
| K180539 | Deformity Analysis and Correction Software (DACS) and Instru | Arrowhead Medical Device Technologies, LLC | 2018-08-13 | 166 | 0 |
| K140550 | ORTHOHUB EXTERNAL FIXATOR SOFTWARE | Orthohub, Inc. | 2014-08-25 | 174 | 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