# K221558: ALPHALOK Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Nov 15, 2022 after 168 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: 13 generations back to K962616 (1996). 106 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212348: ALPHALOK™ Plating System, Vilex, LLC (2022) Summary page 4.
- K190365: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2019) Summary page 5.
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K094037: TC Plating System, Ortho-Pro, LLC (2010) Summary page 5.

## Most influential descendants
- 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 ALPHALOKTM Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: * Forefoot, Midfoot, and Hindfoot Osteotomies * Metatarsals and Metacarpals Corrections and Osteotomies * Stabilization and Fixation of Metatarsal and Metacarpal Fractures * Stabilization and Fixation of Ankle Fractures * Syndesmosis Joint Stabilization * Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints * Flatfoot and Cavus Foot Corrections * Charcot Fixation

Source page: https://510kreport.com/device/K221558
Methodology: https://510kreport.com/methodology