# K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Mar 18, 2002 after 90 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
No predicates in its family tree.
281 later devices descend from it; 16 cite it directly.
1 of 282 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063298: Osteomed Headless Cannulated Screw System (2007), 246 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own

## Indications for use
The Multithread Vilex Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Ostaotomies, Arthrodeses, and Tendon Attachment. Itis intended for, but not limited to, Hand Surgery, Orthopedic and Podiatric Surgery. The materals used to manufacture this screw are 316L, implant-quality stainless steel and TiBAI4V, implant gquality titanium alloy.

Source page: https://510kreport.com/device/K014154
Methodology: https://510kreport.com/methodology