# K042059: Shoulder Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, Inc.
- Decided: Sep 30, 2004 after 62 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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.
33 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051728: Modification to Shoulder Fixation System (2005), 30 descendants of its own
- K060290: Shoulder Fixation System (2006), 25 descendants of its own
- K143697: Biomet Proximal Humerus Plating System (2015), 17 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own

Source page: https://510kreport.com/device/K042059
Methodology: https://510kreport.com/methodology