Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tigon Medical · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
398 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin Al | Tigon Medical | 2026-04-21 | 33 | 0 |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | 2025-12-04 | 111 | 0 |
| K242529 | Tigon Medical All-Suture Anchors (ASA) | Tigon Medical | 2024-12-20 | 116 | 0 |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FI | Tigon Medical | 2024-10-29 | 280 | 0 |
| K220464 | Tigon Medical Gryphon Anchor Line | Tigon Medical | 2023-03-22 | 398 | 0 |
| K211049 | Tigon Medical Button System | Tigon Medical | 2021-08-04 | 118 | 0 |
| K182507 | Tigon Medical Tissue Anchors | Tigon Medical | 2019-01-21 | 131 | 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