# K122411: J-Scope System

- Pathway: 510(k) (Abbreviated)
- Applicant: Myelotec
- Decided: Feb 11, 2013 after 187 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 K833587 (1983). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080560: Henke Sass Wolf of America Arthroscope, Henke Sass Wolf of America, Inc. (2008) Summary page 1.

## Indications for use
The J-Scope System is an endoscopic device intended to be used by physicians for introduction of fluids to assist in visualization of intra-articular structures for arthroscopic diagnosis, as well as for surgical procedures using a second J- Scope or other arthroscopic device. It is indicated for use in the shoulder, hip, wrist, ankle, knee, and elbow joints.

Source page: https://510kreport.com/device/K122411
Methodology: https://510kreport.com/methodology