# K041289: Talus of Vilex (Tov)

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Aug 5, 2004 after 84 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have 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
- K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 (2010), 8 descendants of its own
- K103183: Trilliant Surgical Subtalar Implant (2011), 4 descendants of its own
- K111834: Disco Subtalar Implant (2011), 3 descendants of its own
- K133035: Normed Pellegrin Calcaneus Stop Screw (2013), 2 descendants of its own
- K122738: Gaitway Implant System, Surgical Instrument Set (2012), 2 descendants of its own

## Indications for use
The Talus of Vilex, as designed, has the following Indications for Use: Flat foot, pronated subtalar joint. The material used to manufacture this device is implant-quality titaniumTI6AI4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best removed after the conditions causing the pronation have been corrected. The device is for single use only.

Source page: https://510kreport.com/device/K041289
Methodology: https://510kreport.com/methodology