# K051728: Modification to Shoulder Fixation System

- Pathway: 510(k) (Special)
- Applicant: Hand Innovations, LLC
- Decided: Jul 20, 2005 after 23 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
Longest line of descent: 1 generation back to K042059 (2004). 1 ancestor in all.
30 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042059: Shoulder Fixation System, Hand Innovations, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Indications for use
The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Source page: https://510kreport.com/device/K051728
Methodology: https://510kreport.com/methodology