# K031406: Exojet Tissue Management System

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Worldwide
- Decided: May 30, 2003 after 25 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943450 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020688: Hydrocision Arthojet System with Cautery and Turboburr, Hydrocision, Inc. (2002) Summary page 1.
- K002764: Hydrocision Arthrojet System with Cautery and Burr, Hydrocision, Inc. (2000) Summary page 1.
- K993009: Hydrocision Arthrojet System with Cautery, Hydrocision, Inc. (1999) Summary page 1.
- K982266: Hydrocision Arthrojet System, Hydrocision, Inc. (1998) Summary page 1.

## Indications for use
The Mitek EXOJET system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.

Source page: https://510kreport.com/device/K031406
Methodology: https://510kreport.com/methodology