# K200538: Skeletal Dynamics Forearm Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Jun 1, 2020 after 90 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: 8 generations back to K962616 (1996). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011) Summary page 4.
- K122737: Geminus Fossa Specific Plate System, Skeletal Dynamics, LLC (2012) Summary page 4.

## Most influential descendants
- K242055: Freefix Forearm Plating System (2024), 0 descendants of its own

## Indications for use
The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

Source page: https://510kreport.com/device/K200538
Methodology: https://510kreport.com/methodology