# K260274: Airlock® Ankle Plating System

- Pathway: 510(k) (Abbreviated)
- Applicant: Novastep SAS
- Decided: Mar 25, 2026 after 55 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). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 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.
- K250952: Baby Gorilla®/Gorilla® Plating System, Paragon 28, Inc. (2025) Summary page 6.
- K143523: Airlock osteosynthesis plate system, Novastep (2015) Summary page 6.

## Indications for use
Airlock® Ankle Plating System is indicated for arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints, involving osteotomies of the distal tibia, talus, and calcaneus. The system can be used in adult patients.

Source page: https://510kreport.com/device/K260274
Methodology: https://510kreport.com/methodology