# K173121: Ankle Fusion Plating System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Nov 28, 2017 after 60 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010612 (2001). 182 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073375: Newdeal Tibiaxys System, Newdeal Sas (2008) Summary page 5.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 5.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 5.
- K133691: Extrimilock Ankle Plating System, Osteomed LP (2014) Summary page 5.
- K022255: Modofocation to Synthes Ankle Arthrodesis Plates, Synthes (Usa) (2002) Summary page 5.
- K121425: Ortholoc 3DI Ankle Fusion Plating System, Wrightmedicaltechnologyinc (2012) Summary page 5.

## Most influential descendants
- K213069: CoLink NeoFuse Plating System (2021), 1 descendant of its own
- K241387: CoLink NeoFuse MIS Plating System (see attached parts list) (2024), 0 descendants of its own

## Indications for use
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.

Source page: https://510kreport.com/device/K173121
Methodology: https://510kreport.com/methodology