# K211261: Axis Charcot Fixation System

- Pathway: 510(k) (Special)
- Applicant: Extremity Medical, LLC
- Decided: May 28, 2021 after 32 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K962616 (1996). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System, Extremity Medical, LLC (2017) Summary page 4.
- K190586: Monster® Screw System, Paragon 28, Inc. (2019) Summary page 4.
- K193366: T2 ICF, Stryker GmbH (2020) Summary page 4.
- K140741: Salvation Beams and Bolts System, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Indications for use
The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions 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/K211261
Methodology: https://510kreport.com/methodology