Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trilliant Surgical · 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) |
|---|---|---|---|---|---|
| K212378 | Arsenal Ankle Plating System | Trilliant Surgical | 2022-02-23 | 205 | 0 |
| K191009 | Arsenal Plating System | Trilliant Surgical | 2019-08-12 | 118 | 0 |
| K181898 | Two-Step Implant System | Trilliant Surgical | 2018-10-26 | 102 | 0 |
| K172405 | SNIPER STAPLE SYSTEM, NON-STERILE | Trilliant Surgical | 2017-12-11 | 124 | 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