DeviceClearance

DYNEX® External Fixation Systems— 510(k) K260900

Substantially Equivalent

Vilex, LLC

FDA 510(k) clearance K260900 for DYNEX® External Fixation Systems, Substantially Equivalent on 2026-04-17. Applicant: Vilex, LLC. Device class: 2.

Summary

Vilex's DYNEX External Fixation Systems are filed under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). The record doesn't describe the systems beyond their name and that code name.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).

Vilex filed from Mcminnville, Tennessee. The decision came 30 calendar days after FDA received it (March 18 to April 17, 2026).

Clearance details

Applicant
Vilex, LLC
Product code
Product code KTT
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mcminnville, TN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KTT

view all

More clearances from Vilex, LLC

view all

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.