Trilliant Surgical, Ltd.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Trilliant Surgical, Ltd.” (first 2007, latest 2022), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 122 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 62 |
| 2013 | 2 | 61 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 71 |
| 2017 | 3 | 124 |
| 2018 | 1 | 102 |
| 2019 | 1 | 118 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 205 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Trilliant Surgical, Ltd. took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 7 | 7 |
| HWC | Screw, Fixation, Bone | 7 | 7 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 | 1 |
Review panels
- Orthopedic (18)
Most recent Trilliant Surgical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212378 | Arsenal Ankle Plating System | HRS | 2022-02-23 | 205 |
| K191009 | Arsenal Plating System | HRS | 2019-08-12 | 118 |
| K181898 | Two-Step Implant System | HWC | 2018-10-26 | 102 |
| K172405 | SNIPER STAPLE SYSTEM, NON-STERILE | JDR | 2017-12-11 | 124 |
| K172178 | Minimally Invasive Bunion Plating System | HRS | 2017-11-16 | 120 |
| K162354 | Sniper Staple System | JDR | 2017-04-20 | 240 |
| K160177 | Gridlock Ankle Plating System | HRS | 2016-04-22 | 86 |
| K153338 | Tiger Cannulated Screw System | HWC | 2016-01-14 | 56 |
| K130964 | GRIDLOCK PLATING SYSTEM | HRS | 2013-05-08 | 30 |
| K123525 | GRIDLOCK PLATING SYSTEM | HRS | 2013-02-15 | 92 |
8 earlier clearances. See the full list in Caduvo.
Recalls
24 product recalls in 14 recall events; 0 initiated in the last five years. Most recent: 2019-11-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Trilliant Surgical, Ltd.?
FDA lists 18 510(k) clearances under the applicant name “Trilliant Surgical, Ltd.” (first 2007, latest 2022), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trilliant Surgical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trilliant Surgical, Ltd. is 94 days. Since 2017: 122 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Trilliant Surgical, Ltd.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 7); HWC (Screw, Fixation, Bone, 7); JDR (Staple, Fixation, Bone, 2).
Next steps
- See all 18 Trilliant Surgical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Trilliant Surgical, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.