# K201349: Smith+Nephew Arthroscopes

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Jul 20, 2020 after 60 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 4.

## Indications for use
The Smith+Nephew Arthroscopes is indicated to provide illumination and visualization in: » Diagnostic and Operative arthroscopic procedures for the hip, knee, shoulder, wrist, ankle, elbow, and feet. In addition, Smith+Nephew 4 mm diameter rigid arthroscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Source page: https://510kreport.com/device/K201349
Methodology: https://510kreport.com/methodology