# K140372: Fragment Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Apr 7, 2014 after 52 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: 1 generation back to K081546 (2008). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081546: Small Bone Locking Plating System, DePuy Orthopaedics, Inc. (2008) Summary page 1.

## Most influential descendants
- K241815: Protean Fragment Plating System (2024), 0 descendants of its own
- K213214: Xpert Wrist (2021), 0 descendants of its own

## Indications for use
The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly In osteopenic bone.

Source page: https://510kreport.com/device/K140372
Methodology: https://510kreport.com/methodology