# K182201: Stratum™ Foot Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Nov 16, 2018 after 94 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K041081 (2004). 7 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.
- K140724: MSP Metatarsal Shortening System, Nextremity Solutions, Inc. (2014) Summary page 4.
- K131670: Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right), Biomet, Inc. (2013) Summary page 4.

## Most influential descendants
- K212979: CalcShift™ Displacement Calcaneal Osteotomy System (2022), 0 descendants of its own
- K213301: InCore Subtalar System (2021), 0 descendants of its own
- K212640: Stratum® Ankle Fusion Plating System (2021), 0 descendants of its own
- K200785: Stratum™ Reduced Size Foot Plating System (2020), 0 descendants of its own

## Recalls of this device
- Dec 16, 2019 · Class II · Z-1127-2020: The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
- Nov 11, 2019 · Class II · Z-0776-2020: Components 2mm shorter than indicated on the package label
- Nov 11, 2019 · Class II · Z-0777-2020: Components 2mm shorter than indicated on the package label
- Nov 11, 2019 · Class II · Z-0778-2020: Components 2mm shorter than indicated on the package label
- Oct 9, 2019 · Class II · Z-0534-2020: Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

## Indications for use
The Nextremity Solutions Stratum™ Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K182201
Methodology: https://510kreport.com/methodology