# K200067: MectaScope System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Oct 1, 2020 after 262 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: 1 generation back to K943052 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943052: Arthroscopic Telescopes, Karl Storz Endoscopy (1995) Summary page 4.

## Indications for use
MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.

Source page: https://510kreport.com/device/K200067
Methodology: https://510kreport.com/methodology