# K212348: ALPHALOK™ Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: May 2, 2022 after 278 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 97 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041287: Vilex Bone Plate System, Vilex, Inc. (2004) Summary page 4.
- K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), Synthes (USA) Products, LLC (2015) Summary page 4.
- K131566: Arix Hand System, Jeil Medical Corporation (2013) Summary page 4.

## Most influential descendants
- K221558: ALPHALOK Plating System (2022), 2 descendants 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
ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.

Source page: https://510kreport.com/device/K212348
Methodology: https://510kreport.com/methodology