# K241815: Protean Fragment Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Sep 26, 2024 after 94 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: 17 generations back to K962616 (1996). 297 ancestors in all.
No later device cites it as a predicate yet.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), Synthes (USA) Products, LLC (2015) Summary page 5.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 5.
- K212433: Anthem Fracture System, Globus Medical, Inc. (2021) Summary page 5.
- K140372: Fragment Plate System, Skeletal Dynamics, LLC (2014) Summary page 5.

## Indications for use
The Skeletal Dynamics Protean Fragment Plating System is intended for stabilization and fixation in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, clavicle, scapula, finger, toe, and pelvis, particularly in osteopenic bone with the appropriate configuration of the device. The system is intended for use in adult and pediatric populations (children and adolescents).

Source page: https://510kreport.com/device/K241815
Methodology: https://510kreport.com/methodology