# K192994: Paragon 28 APEX 3D Total Ankle Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jul 10, 2020 after 259 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: 8 generations back to K920802 (1992). 30 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171067: INVISION Total Ankle Revision System, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K153452: Salto XT, Salto Talaris, Tornier S.A.S. (2016) Summary page 5.
- K151459: Integra Total Ankle Replacement System, Ascension Orthopedics (2015) Summary page 5.

## Most influential descendants
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 descendants of its own
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own
- K202019: Maven Patient-Specific Instrumentation (2021), 1 descendant of its own
- K250641: APEX 3D Total Ankle Replacement System (2025), 0 descendants of its own
- K240259: APEX 3D Total Ankle Replacement 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/K192994
Methodology: https://510kreport.com/methodology