# K984304: Riwo Drive Generator

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Aug 12, 1999 after 253 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871250 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970088: Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1:, Richard Wolf Medical Instruments Corp. (1997) Summary page 1.

## Most influential descendants
- K080617: Power Drive ART1 2304 with Motor Handles, Tools and Accessories (2008), 0 descendants of its own

## Recalls of this device
- Nov 25, 2015 · Class II · Z-0791-2016: Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
- Nov 25, 2015 · Class II · Z-0789-2016: Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
- Nov 25, 2015 · Class II · Z-0790-2016: Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.

## Indications for use
The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures. Indication and field of application: For therapy with endoscopic accessories: in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intra-articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures in sinus surgery, e.g., for removal of polyps in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy) Contraindications: Contraindications are given in cases where the clinical condition of the patient or the specific case increases significantly the risk to the patient if motorized instrumentation is applied. This might result in an absolute or a relative contraindication,

Source page: https://510kreport.com/device/K984304
Methodology: https://510kreport.com/methodology