# K212640: Stratum® Ankle Fusion Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Nov 18, 2021 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: 15 generations back to K954385 (1996). 230 ancestors in all.
No later device cites it as a predicate yet.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182148: SILVERBACK Gorilla Plating System, Paragon 28, Inc. (2018) Summary page 4.
- K123347: Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0, Normed Medizin-Technik GmbH (2013) Summary page 4.
- K182201: Stratum™ Foot Plating System, Nextremity Solutions, Inc. (2018) Summary page 4.

## Indications for use
The Stratum Ankle Fusion Plating System is indicated for use in stabilization and fixation of fractures or osteotomies, intra and extra articular fractures, and multi-fragmentary fractures, revision procedures, non-union and malunion, joint fusion and reconstruction of small bones of the feet and ankles including the distal tibia, talus, and calcaneus.

Source page: https://510kreport.com/device/K212640
Methodology: https://510kreport.com/methodology