# K250622: Succession™ AFN System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions UK, Ltd.
- Decided: Aug 7, 2025 after 160 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K982953 (1998). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121575: Oxford Ankle Fusion Nail (Afn) System, Ortho Solutions Limited (2012) Summary page 5.
- K173811: TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System, In2bones Sas (2018) Summary page 5.

## Indications for use
The Succession TM Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications: - Failed ankle replacement - Arthritis of ankle and subtalar joint - Correcting neuromuscular imbalance of hindfoot, where bone fusion is required - Revision of failed ankle and/or subtalar fusion - Revision of failed Tibiotalocalcaneal (TTC) fusion - Talar Avascular Necrosis (AVN) - Charcot - Trauma - Neuroarthropathy - Pseudoarthrosis - Rheumatoid arthritis

Source page: https://510kreport.com/device/K250622
Methodology: https://510kreport.com/methodology