# K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Jul 13, 2017 after 99 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: 12 generations back to K962616 (1996). 93 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140741: Salvation Beams and Bolts System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K151418: Monster Screw System, Paragon 28 (2015) Summary page 4.
- K082934: Extremity Medical Midfoot Screw System, Extremity Medical, LLC (2009) Summary page 4.

## Most influential descendants
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K203011: Monster Screw System (2020), 6 descendants of its own
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (2023), 4 descendants of its own

## Indications for use
Axis Charcot Fixation System: The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm 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 osteoarthopathy (Charcot). 4.5 to 8.5 Screw System: The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

Source page: https://510kreport.com/device/K171018
Methodology: https://510kreport.com/methodology