510(k) Report

510(k) · Cleared

Cleared

Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1:

K970088510(k) TraditionalCleared Apr 7, 199787-day reviewClass I21 CFR 878.4820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corp. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Cleared on Apr 7, 1997 as substantially equivalent to K871250 (Richard Wolf Medical Instruments Corp., 1987) after an 87-day review. Its family tree reaches back 1 generation to 1987. 11 later devices descend from it.

Decided
Apr 7, 1997
Review
87 days
Class
Class I
Product code
HWE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K871250 (1987). 11 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared1999: 2 descendants cleared2008: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2024: 1 descendant clearedK871250 · Intra-Articulated Arthro Power System · Richard Wolf Medical Instruments Corp. · 19871990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 3 descendants K871250 · Intra-Articulated Arthro Power System · Richard Wolf Medical Instruments Corp. · 19870
  1. Root · 1 generation backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
  2. This deviceK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
  3. Descendant · cites it directly · 9 of its ownK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
  4. Descendant · cites it directly · 8 of its ownK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
  5. Descendant · 2 generations on · 6 of its ownK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
  6. Descendant · 3 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
  7. Descendant · 3 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1999: 22003: 12004: 12008: 12011: 12020: 12023: 12024: 12026: 2
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 11 · See all
  • K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp. · 1999 · cites it directly9descendants
  • K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp. · 2003 · cites it directly8descendants
  • K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004 · 2 generations on6descendants
  • K192499Cyber BladeSIDAM S.r.l. · 2020 · 3 generations on2descendants
  • K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K871250Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp.1987—
0 (this device)K970088Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary…Richard Wolf Medical Instruments Corp.1997—
+1K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp.1999—
+1K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp.2003—
+2K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp.2004—
+3K192499Cyber BladeSIDAM S.r.l.2020—
+3K213597MultiCut SoloAsclepion Laser Technologies GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200310
200410
200810
201110
202010
202310
202410
202620
FIG. 1 — Lineage of K970088, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K871250Intra-Articulated Arthro Power System
Summary page 1
…n name: Drive Generator Instrument, surgical, orthopedic, DC-powerded o motor and accessory/attachment 510(k) Trade or proprietary or model nanu Manufacturer Number 1 K871250 1 intra-articulated arthro power system 2161 1 Richard Wolf M.I.C. 2 2 Surgical Drive System EP-1 2 Dyonics 3 3 Shaver System S…
Richard Wolf Medical Instruments Corp.1987—
*—Surgical Drive System EP-1
Named without a submission number
—
*—Shaver System SE
Named without a submission number
—
*—Drive System Apex
Named without a submission number
—

Also cleared against K871250: 2 other devices →

What descends from it? (11)

See all 11

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp.19999
K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp.20038
K984304Riwo Drive GeneratorRichard Wolf Medical Instruments Corp.19991
K080617Power Drive ART1 2304 with Motor Handles, Tools and AccessoriesRichard Wolf Medical Instruments Corp.20080

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?

  • Its one ancestor has no recall.
  • Of its descendants, K984521 (Richard Wolf Medical Instruments Corp., 1999) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K871250.

How does its category compare?

All HWE devices

HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWE

1in 2015

2007: 12011: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWE

Too few HWE 510(k)s in any year since 2007 to give a median.

Recalls per year · HWE

1in 2017

2009: 42010: 22011: 22013: 12014: 32015: 52016: 22017: 1
2007high 5 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWE

2,848in 2025

2007: 1232008: 722009: 1802010: 2972011: 1382012: 2212013: 1,2432014: 3,7942015: 5,5672016: 4,9742017: 5,0742018: 3,5892019: 3,4522020: 3,2482021: 3,1402022: 3,3272023: 3,3972024: 3,6862025: 2,848
2007high 5,567 (2015) · low 72 (2008)2025

MAUDE reports naming product code HWE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0123
20080—072
20090—4180
20100—2297
20111—2138
20120—0221
20130—11,243
20140—33,794
20151—55,567
20160—24,974
20170—15,074
20180—03,589
20190—03,452
20200—03,248
20210—03,140
20220—03,327
20230—03,397
20240—03,686
20250—02,848
20260—0—

What is it indicated for?

The Riwo Drive System is used for arthroscopic procedures in human joints.

It is also used for sinus procedures in the nasal cavity.

The Riwo Drive generator with motor handle serves to drive WOLF blades or abraders.

Depending on the indication, different styles of blades are attached to the motor handle. Two basic styles are most common:

1. Blades are for removal of soft tissue and cartilage

2. Abraders for bones and bony structures

The use of the system is reserved to surgeons with special training in the respective procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K871250

2 other devices cite the same predicate.

  • K080617Power Drive ART1 2304 with Motor Handles, Tools and AccessoriesRichard Wolf Medical Instruments Corp. · 2008
  • K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp. · 2003

More from Richard Wolf Medical Instruments Corp.

146 FDA decisions under this applicant name. See the company

  • P870080/S002Hulka Clip for Tubal OcclusionRichard Wolf Medical Instruments Corp. · 2016
  • K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar…Richard Wolf Medical Instruments Corp. · 2012

Recent decisions in HWE

The HWE category page

  • K143191IntelliSense DrillMcginley Innovations · 2015
  • K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011
  • K063688Surgical Irrigation System, Irrigation TubeThe Anspach Effort, Inc. · 2007
  • K050766Explant Osteonecrosis Intervention Implant Removal SystemZimmer Trabecular · 2005
  • K043310Synthes (Usa) Electric Pen Drive SystemSynthes (Usa) · 20052 Class I recalls

https://510kreport.com/device/K970088 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970088: Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1:.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970088

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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