# K200785: Stratum™ Reduced Size Foot Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Jul 27, 2020 after 123 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: 5 generations back to K041081 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 4.
- K140724: MSP Metatarsal Shortening System, Nextremity Solutions, Inc. (2014) Summary page 4.
- K182201: Stratum™ Foot Plating System, Nextremity Solutions, Inc. (2018) Summary page 4.

## Indications for use
The Nextremity Solutions Stratum™ Reduced Size Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K200785
Methodology: https://510kreport.com/methodology