# K042358: Locon VLS Distal Radius Plate System

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 7, 2004 after 37 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LOCON-T® Distal Radial Plate System: named in the summary without a submission number

## Indications for use
The LOCONTM VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable: · Joint destruction and/or subluxation visible on x-ray; • Failed fracture fixation with or without bone graft; * Osteotomy and repair of distal radius malunion with or without bone graft; * Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone; • Volar plates are indicated for use with comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator; * Locking volar plates are indicated for use with volar articular shearing fractures

Source page: https://510kreport.com/device/K042358
Methodology: https://510kreport.com/methodology