# K202373: APEX 3D Total Ankle Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Nov 13, 2020 after 86 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: 14 generations back to K810258 (1981). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 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.
- K152893: Corin Optimized Positioning System (OPS), Corin USA (2016) Summary page 5.

## 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/K202373
Methodology: https://510kreport.com/methodology