# K900070: Modified Uses of the Arthroscopic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Dyonics, Inc.
- Decided: Feb 16, 1990 after 43 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 K833587 (1983). 2 ancestors in all.
61 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833587: Disposable Arthroscopy Blade, Dyonics, Inc. (1983) Summary page 8.
- K880150: Pacesetter (TM) 3500 Arthroscopic Surgical System, Dyonics, Inc. (1988) Summary page 8.

## Cited in the summary but kept off the family tree
- K771218A: Arthroscopic Surgical System. Number could not be read Summary page 8.
- K8202367: Unnamed device. Number could not be read Summary page 8.

## 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
All patients are eligible for this procedure if they meet the following criteria: A. Unremitting, persistent radiculopathy at L3-L4, L4-L5, or L5-S1 locations. B. Failure to respond to conservative therapy. C. VNeurological impairment as reflected by sensory deficits, reflex abnormalities and motor weakness. D. Correlative electromyography in the absence of correlative neurological deficits. E. Positive tension signs. F. Correlative imaging studies showing subannular herniated nucleus pulposus consistent with clinical findings.

Source page: https://510kreport.com/device/K900070
Methodology: https://510kreport.com/methodology