# K250304: TITANEX Screw Systems

- Pathway: 510(k) (Special)
- Applicant: Vilex, LLC
- Decided: Mar 5, 2025 after 30 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991197 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231504: TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System, Vilex, LLC (2023) Summary page 5.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999) Summary page 5.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 5.

## Most influential descendants
- K260900: DYNEX® External Fixation Systems (2026), 0 descendants of its own

## Indications for use
The TITAN EX® Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

Source page: https://510kreport.com/device/K250304
Methodology: https://510kreport.com/methodology