# K041287: Vilex Bone Plate System

- 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.
7 later devices descend from it; 4 cite it directly.
0 of 8 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
- K212348: ALPHALOK™ Plating System (2022), 3 descendants of its own
- K221558: ALPHALOK Plating System (2022), 2 descendants of its own
- K200108: GEO 1st MTP Joint Arthrodesis Plating System (2020), 1 descendant of its own
- K233816: REDEMPTION Charcot Plating System (2024), 0 descendants of its own
- K230204: ALPHALOK Plating System (2023), 0 descendants of its own

## Indications for use
The Vilex Bone Plates have the following Indications for Use: Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

Source page: https://510kreport.com/device/K041287
Methodology: https://510kreport.com/methodology