# K200701: Skeletal Dynamics Midshaft Humerus Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: May 14, 2020 after 57 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: 15 generations back to K962616 (1996). 142 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 4.
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws, Meril Healthcare Pvt., Ltd. (2018) Summary page 4.

## Indications for use
The Skeletal Dynamics Midshaft Humerus Plating System is indicated for fixation of the humerus for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.

Source page: https://510kreport.com/device/K200701
Methodology: https://510kreport.com/methodology