Vilex, LLC: FDA clearances and approvals
Vilex, LLC has 30 FDA 510(k) clearances (first 1998, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time: 106 days. Since 2017 its median was 110 days, against 104 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 377 |
| 2013 | 0 | — |
| 2014 | 1 | 317 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 36 |
| 2021 | 1 | 60 |
| 2022 | 3 | 218 |
| 2023 | 4 | 100 |
| 2024 | 5 | 266 |
| 2025 | 1 | 30 |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, Vilex, LLC's cleared 510(k)s took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 9 | 9 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 5 | 5 |
| HRS | Plate, Fixation, Bone | 4 | 4 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| HTN | Washer, Bolt Nut | 2 | 2 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
Review panels
- Orthopedic (30)
Most recent Vilex, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260900 | DYNEX® External Fixation Systems | KTT | 2026-04-17 | 30 |
| K250304 | TITANEX Screw Systems | HWC | 2025-03-05 | 30 |
| K240475 | Hintermann Series H2 Total Ankle System | HSN | 2024-12-02 | 286 |
| K243408 | TACTIX Vector Syndesmosis System | HTN | 2024-11-27 | 26 |
| K233816 | REDEMPTION Charcot Plating System | HRS | 2024-08-28 | 272 |
| K240035 | TACTIX Vector Syndesmosis System | HTN | 2024-08-01 | 210 |
| K231343 | Redemption Duo Hindfoot Nail System | HSB | 2024-01-30 | 266 |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System | HWC | 2023-09-11 | 110 |
| K231493 | NITINEX Memory Compression Staple | JDR | 2023-08-11 | 80 |
| K230462 | OPTIX H2 Patient Specific Instrument System | HSN | 2023-07-17 | 146 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vilex, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vilex, LLC have?
Vilex, LLC has 30 FDA 510(k) clearances (first 1998, latest 2026), across 9 product codes in 1 review panel.
How long does FDA take to clear Vilex, LLC's 510(k)s?
The median time from FDA receipt to decision across Vilex, LLC's cleared 510(k)s is 106 days. Since 2017: 110 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does Vilex, LLC make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 9); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 5); HRS (Plate, Fixation, Bone, 4).
Has Vilex, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Vilex, LLC. Related entities may recall under other names.
Next steps
- See all 30 Vilex, LLC clearances with predicates and recalls
- Run predicate analysis for product code HWC, Vilex, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.