510(k) · Cleared
ClearedPower Drive ART1 2304 with Motor Handles, Tools and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HRX Arthroscope
Cleared on Jun 27, 2008 as substantially equivalent to K030082 (Richard Wolf Medical Instruments Corp., 2003) and 4 other predicates after a 115-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Jun 27, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K871250 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
- 3 generations backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
- 2 generations backK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- 1 generation backK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- This deviceK080617 Power Drive ART1 2304 with Motor Handles, Tools and AccessoriesRichard Wolf Medical Instruments Corp. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | 1987 | — |
| −3 | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| −2 | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | 1999 | — |
| −1 | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003 | — |
| 0 (this device) | K080617 | Power Drive ART1 2304 with Motor Handles, Tools and Accessories | Richard Wolf Medical Instruments Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Summary page 1…sories/attachments. Information ndeietohchusaalegivalence is- claed 510(k) Number Trade or proprietary or model name Manufacturer 1 K030082 1 Power Control 2303 with Power Stick M4 1 Richard Wolf 2 K871250 2 Intra-articulated arthro powe… | 2003 |
| * | K871250 | Intra-Articulated Arthro Power SystemSummary page 1…Trade or proprietary or model name Manufacturer 1 K030082 1 Power Control 2303 with Power Stick M4 1 Richard Wolf 2 K871250 2 Intra-articulated arthro power system 2161 2 Richard Wolf 3 K970088 3 RIWO DRIVE Generator with Foo… | 1987 |
| * | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and…Summary page 1…1 Power Control 2303 with Power Stick M4 1 Richard Wolf 2 K871250 2 Intra-articulated arthro power system 2161 2 Richard Wolf 3 K970088 3 RIWO DRIVE Generator with Footswitch, Motor 3 Richard Wolf handles and Single Use Rotar… | 1997 |
| * | K984304 | Riwo Drive GeneratorSummary page 1…Motor 3 Richard Wolf handles and Single Use Rotary Blades and Abraders 4 RIWO DRIVE Generator, single use or reusable 4 K984304 Rotary Cutters and BurrsWolf 5 K984521 5 RIWO DRIVE small handle 5 Richard Wolf… | 1999 |
| * | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Summary page 1…handles and Single Use Rotary Blades and Abraders 4 RIWO DRIVE Generator, single use or reusable 4 K984304 Rotary Cutters and BurrsWolf 5 K984521 5 RIWO DRIVE small handle 5 Richard Wolf 1.0 Description The POWER DRIVE ART… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K030082.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
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: ·…
Read the full statement (125 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080617: Power Drive ART1 2304 with Motor Handles, Tools and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080617
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026