# K080617: Power Drive ART1 2304 with Motor Handles, Tools and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jun 27, 2008 after 115 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 K871250 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030082: Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851, Richard Wolf Medical Instruments Corp. (2003) Summary page 1.
- K871250: Intra-Articulated Arthro Power System, Richard Wolf Medical Instruments Corp. (1987) Summary page 1.
- 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.
- K984304: Riwo Drive Generator, Richard Wolf Medical Instruments Corp. (1999) Summary page 1.
- K984521: Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351, Richard Wolf Medical Instruments Corp. (1999) Summary page 1.

## Indications for use
In conjunction with a motorized handle (e.g. Power Stick M5/3), the POWER DRIVE ARTI 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill MI, bones can be severed or machined. The product is used in conjunction with endoscopic accessories for the following purposes: · In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications). * In surgery, e.g. for the removal of hematomas. · In sinus surgery, e.g. for the removal of polyps. · In spinal surgery (arthroscopic microdiskectomy (AMD) for removing degenerated tissue.

Source page: https://510kreport.com/device/K080617
Methodology: https://510kreport.com/methodology