# K961228: Karl Storz Magnifying Arthrosocpes

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Oct 10, 1996 after 195 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
No predicates in its family tree.
61 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K971253: Various Arthroscopes, Endoscopic Blades, Manual Instruments (1997), 60 descendants of its own
- K043395: Smith & Nephew Videoarthroscope (2005), 32 descendants of its own
- K072879: Innervue Diagnostic Scope System (2008), 30 descendants of its own
- K082293: Surgview Integrated Visualization System (2008), 21 descendants of its own
- K080560: Henke Sass Wolf of America Arthroscope (2008), 21 descendants of its own

## Indications for use
The KSEA magnifying arthroscopes and accessories are intended for use by qualified surgeons during arthroscopic procedures of the small and large joints. Specific arthroscope models are intended for arthroscopic procedures of the shoulder and knee; arthroscopic procedures of the elbow, ankle, wrist and jaw; and arthroscopic procedures for the shoulder, knee and illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint

Source page: https://510kreport.com/device/K961228
Methodology: https://510kreport.com/methodology