# K162996: INVISIKNOT Ankle Syndesmosis Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 8, 2017 after 224 days
- Product code: HTN (Washer, Bolt Nut)
- 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: 7 generations back to K792022 (1979). 44 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 4.

## Most influential descendants
- K242091: Bolo Button System (2024), 0 descendants of its own
- K233531: OIC FLEX-FIX™ System (2024), 0 descendants of its own

## Indications for use
The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

Source page: https://510kreport.com/device/K162996
Methodology: https://510kreport.com/methodology