Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Vilex, LLC — Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

110 daysmedian FDA review time
278 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260900DYNEX® External Fixation SystemsVilex, LLC2026-04-17300
K250304TITANEX Screw SystemsVilex, LLC2025-03-05300
K240475Hintermann Series H2 Total Ankle SystemVilex, LLC2024-12-022860
K243408TACTIX Vector Syndesmosis SystemVilex, LLC2024-11-27260
K233816REDEMPTION Charcot Plating SystemVilex, LLC2024-08-282720
K240035TACTIX Vector Syndesmosis SystemVilex, LLC2024-08-012100
K231343Redemption Duo Hindfoot Nail SystemVilex, LLC2024-01-302660
K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystVilex, LLC2023-09-111100
K231493NITINEX Memory Compression StapleVilex, LLC2023-08-11800
K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC2023-07-171460
K230204ALPHALOK Plating SystemVilex, LLC2023-04-25900
K221342REDEMPTION Beaming SystemVilex, LLC2022-12-132180
K221558ALPHALOK Plating SystemVilex, LLC2022-11-151680
K212348ALPHALOK™ Plating SystemVilex, LLC2022-05-022780
K212552Correx SoftwareVilex, LLC2021-10-12600
K202143Dynex MicroVilex, LLC2020-09-11420
K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC2020-08-24310

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