Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paradigm Spine — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213493 | Fortilink with TiPlus Technology | Paradigm Spine | 2022-01-27 | 87 | 0 |
| K071668 | ORTHOBIOM SPINAL SYSTEM | Paradigm Spine | 2008-07-02 | 379 | 0 |
| K080963 | DSS STABILIZATION SYSTEM | Paradigm Spine | 2008-05-02 | 28 | 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