# K230623: KITE Distal Fibula Kit

- Pathway: 510(k) (Traditional)
- Applicant: Intrauma S.P.A
- Decided: Sep 1, 2023 after 179 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: 2 generations back to K190365 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K203511: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2020) Summary page 4.

## Indications for use
The KITE Distal Fibula Kit is indicated for: - Diaphyseal and metaphyseal fractures of the distal fibula - Intra and extra articular fractures of the distal fibula - Non-unions of the distal fibula

Source page: https://510kreport.com/device/K230623
Methodology: https://510kreport.com/methodology