Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthofix US, LLC — 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) |
|---|---|---|---|---|---|
| K252088 | Firebird SI Navigation System | Orthofix US, LLC | 2025-10-31 | 121 | 0 |
| K230252 | OFIX MIS App | Orthofix US, LLC | 2023-09-26 | 239 | 0 |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervic | Orthofix US, LLC | 2022-02-11 | 253 | 0 |
| K213951 | FORZA XP Expandable Spacer System | Orthofix US, LLC | 2022-01-05 | 19 | 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