# K210390: Apex 3D Total Ankle Replacement System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Mar 6, 2021 after 25 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K920802 (1992). 31 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System, Paragon 28, Inc. (2020) Summary page 4.

## Most influential descendants
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own
- K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System (2024), 0 descendants of its own

## Indications for use
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

Source page: https://510kreport.com/device/K210390
Methodology: https://510kreport.com/methodology