510(k) · Cleared
ClearedPower Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851
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 Oct 30, 2003 as substantially equivalent to K871250 (Richard Wolf Medical Instruments Corp., 1987) and 3 other predicates after a 294-day review. Its family tree reaches back 3 generations to 1987. 8 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 294 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K871250 (1987). 7 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
- 2 generations backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
- 1 generation backK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- This deviceK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- Descendant · cites it directly · 6 of its ownK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
- Descendant · 2 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
- Descendant · 2 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK260884 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
- Descendant · 3 generations on · 0 of its ownK251923 Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004 · cites it directly6descendants
- K192499Cyber BladeSIDAM S.r.l. · 2020 · 2 generations on2descendants
- K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 2 generations on1descendant
- K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026 · 3 generations on0descendants
- K251923Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | 1987 | — |
| −2 | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| −1 | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | 1999 | — |
| 0 (this device) | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +1 | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | 2004 | — |
| +2 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| +2 | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
| +3 | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026 | — |
| +3 | K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K871250 | Intra-Articulated Arthro Power SystemSummary page 1…Electric surgical rotary blade/ abrader 5 10(k) Trade or proprietary or model name Manufacturer Number 1 K871250 1 Intra-articulated arthro power system 2161 1 Richard Wolf 2 K970088 2 RlWO DRIVE 2302 Generator and… | 1987 |
| * | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and…Summary page 1…oprietary or model name Manufacturer Number 1 K871250 1 Intra-articulated arthro power system 2161 1 Richard Wolf 2 K970088 2 RlWO DRIVE 2302 Generator and accessories 2 Richard Wolf 3 K984521 3 RlWO DRIVE small handle… | 1997 |
| * | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Summary page 1…1 Intra-articulated arthro power system 2161 1 Richard Wolf 2 K970088 2 RlWO DRIVE 2302 Generator and accessories 2 Richard Wolf 3 K984521 3 RlWO DRIVE small handle 3 Richard Wolf 4 KO02328 4 SIOS-Interface for various de… | 1999 |
| * | K002328 | Sios-Interface for Auto Light Projector, Sios-Interface for 3 CCD Endocam… | 2001 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K041610 (Richard Wolf Medical Instruments Corp., 2004) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K871250.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Power Control 2303 in connection with Power Stick M4 (8564.121) or alternatively Power Stick M3 (8563.111/311) serves to drive Wolf rotary bladed abraders and morcellators (tissue punches) for removal of tissue in endoscopic operations. At the same time aspiration allows continuous removal of ablated tissue. For use with endoscopic accessories: In arthroscopy, e.g. for meniscus resection, removal of soft tissue as well as intraarticular severing or…
Read the full statement (105 words)
The Power Control 2303 in connection with Power Stick M4 (8564.121) or alternatively Power Stick M3 (8563.111/311) serves to drive Wolf rotary bladed abraders and morcellators (tissue punches) for removal of tissue in endoscopic operations. At the same time aspiration allows continuous removal of ablated tissue.
For use with endoscopic accessories:
In arthroscopy, e.g. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations)
In thorax surgery, e.g. for removing hematomas
In sinus surgery, e.g. for removing of polyps
In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030082: Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030082
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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