# K202307: Activ Fuse

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Nov 17, 2020 after 95 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: 13 generations back to K010612 (2001). 163 ancestors in all.
No later device cites it as a predicate yet.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121425: Ortholoc 3DI Ankle Fusion Plating System, Wrightmedicaltechnologyinc (2012) Summary page 5.
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 5.
- K190953: Arthrex Minimally Invasive Ankle Fusion Plate, Arthrex, Inc. (2019) Summary page 5.

## Indications for use
The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

Source page: https://510kreport.com/device/K202307
Methodology: https://510kreport.com/methodology