# K121575: Oxford Ankle Fusion Nail (Afn) System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions Limited
- Decided: Sep 14, 2012 after 107 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982953 (1998). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023115: Ace Versanail, DePuy Orthopaedics, Inc. (2002) Summary page 1.
- K003797: Ace Aim TTC Fusion Nail, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K043052: Trigen Hindfoot Fusion Nail, Smith & Nephew, Inc. (2004) Summary page 1.
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 1.
- K020384: T2 Arthrodesis Nail System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail, Biomet Trauma (2009) Summary page 1.
- K081243: Biomet Phoenix Ankle Nail System, Biomet Trauma (2008) Summary page 1.
- K110552: Valor (R) Ankle Fusion Nail System Screw, Wrightmedicaltechnologyinc (2011) Summary page 1.
- K090857: Valor Ankle Fusion Nail System, Wrightmedicaltechnologyinc (2009) Summary page 1.
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL, Newdeal Sas (2009) Summary page 1.
- K050882: Newdeal Ankle Nail, New Deal, S.A. (2005) Summary page 1.

## Most influential descendants
- K250622: Succession™ AFN System (2025), 0 descendants of its own

## Recalls of this device
- Apr 19, 2017 · Class II · Z-2780-2017: There is a material mislabeling of the AFN End Cap.

## Indications for use
The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TIC) 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 Tibiota local canealI (TTC) fusion > Talar Avascular Necrosis (AFN) > Charcot > Trauma > Neuroarthropathy > Pseudoarthrosis > Rheumatoid arthritis

Source page: https://510kreport.com/device/K121575
Methodology: https://510kreport.com/methodology