# K210157: SOLE Medial Column Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Apr 20, 2021 after 89 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: 14 generations back to K792022 (1979). 220 ancestors in all.
No later device cites it as a predicate yet.
0 of 221 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203511: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2020) Summary page 4.
- K180500: VariAx 2 System, Stryker GmbH (2018) Summary page 4.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 4.
- K140792: Salvation 3DI Plating System, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Indications for use
The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include: - Arthrodesis; - Joint depression stabilization; - Fracture and/or osteotomy fixation; - Reconstruction; - Revision to be performed for conditions such as Charcot neuroarthropathy.

Source page: https://510kreport.com/device/K210157
Methodology: https://510kreport.com/methodology