# K192592: Axis Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Nov 21, 2019 after 62 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). 236 ancestors in all.
No later device cites it as a predicate yet.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190365: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2019) Summary page 4.
- K180808: Omni Foot Plating System, Extremity Medical, LLC (2018) Summary page 4.

## Indications for use
The Axis Plating System is indicated for stabilization and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).

Source page: https://510kreport.com/device/K192592
Methodology: https://510kreport.com/methodology