# K230204: ALPHALOK Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Apr 25, 2023 after 90 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: 14 generations back to K962616 (1996). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System, Wrightmedicaltechnologyinc (2017) Summary page 6.
- K221558: ALPHALOK Plating System, Vilex, LLC (2022) Summary page 6.
- K212348: ALPHALOK™ Plating System, Vilex, LLC (2022) Summary page 6.

## Indications for use
The ALPHALOKT™ 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 The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: » Lateral Malleolar Fractures » Syndesmosis Injuries » Medial Malleolar Fractures » Bi-Malleolar Fractures » Tri-Malleolar Fractures » Posterior Malleolar Fractures » Distal Anterior Tibia Fractures » Vertical Shear Fractures of the Medial Malleolus » Pilon Fractures * Distal Tibia Shaft Fractures » Distal Fibula Shaft Fractures » Distal Tibia Periarticular Fractures » Medial Malleolar Avulsion Fractures » Lateral Malleolar Avulsion Fractures

Source page: https://510kreport.com/device/K230204
Methodology: https://510kreport.com/methodology