Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trilliant Surgical, Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
160 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172178 | Minimally Invasive Bunion Plating System | Trilliant Surgical, Ltd. | 2017-11-16 | 120 | 0 |
| K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017-04-20 | 240 | 0 |
| K160177 | Gridlock Ankle Plating System | Trilliant Surgical, Ltd. | 2016-04-22 | 86 | 0 |
| K153338 | Tiger Cannulated Screw System | Trilliant Surgical, Ltd. | 2016-01-14 | 56 | 1 |
| K130964 | GRIDLOCK PLATING SYSTEM | Trilliant Surgical, Ltd. | 2013-05-08 | 30 | 0 |
| K123525 | GRIDLOCK PLATING SYSTEM | Trilliant Surgical, Ltd. | 2013-02-15 | 92 | 0 |
| K122959 | HAMMER TOE IMPLANT | Trilliant Surgical, Ltd. | 2012-11-07 | 43 | 0 |
| K121452 | GRIDLOCK PLATING SYSTEM | Trilliant Surgical, Ltd. | 2012-08-20 | 96 | 3 |
| K121008 | TRILLIANT SURGICAL K-WIRES | Trilliant Surgical, Ltd. | 2012-06-04 | 62 | 1 |
| K111834 | DISCO SUBTALAR IMPLANT | Trilliant Surgical, Ltd. | 2011-12-06 | 160 | 0 |
| K112737 | TIGER HEADLESS CANNULATED SCREWS | Trilliant Surgical, Ltd. | 2011-10-20 | 30 | 2 |
| K103183 | TRILLIANT SURGICAL SUBTALAR IMPLANT | Trilliant Surgical, Ltd. | 2011-02-08 | 103 | 0 |
| K081510 | TIGER CANNULATED SCREW SYSTEM | Trilliant Surgical, Ltd. | 2008-08-04 | 67 | 4 |
| K072922 | 3S HEMI TOE | Trilliant Surgical, Ltd. | 2007-11-28 | 44 | 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