510(k) · Cleared
Recalled · Class II · 2015Riwo Drive Generator
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 Aug 12, 1999 as substantially equivalent to K970088 (Richard Wolf Medical Instruments Corp., 1997) after a 253-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Aug 12, 1999
- Review
- 253 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871250 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
- 1 generation backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
- This deviceK984304 Riwo Drive GeneratorRichard Wolf Medical Instruments Corp. · 1999
- Descendant · cites it directly · 0 of its ownK080617 Power Drive ART1 2304 with Motor Handles, Tools and AccessoriesRichard Wolf Medical Instruments Corp. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080617Power Drive ART1 2304 with Motor Handles, Tools and AccessoriesRichard Wolf Medical Instruments Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | 1987 | — |
| −1 | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| 0 (this device) | K984304 | Riwo Drive Generator | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +1 | K080617 | Power Drive ART1 2304 with Motor Handles, Tools and Accessories | Richard Wolf Medical Instruments Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and…Summary page 1…tters and Burrs Cutlers and Burrs Information on devices to which substantial equivalence is claimed: 510(k) Number Trade ot proprictary or model name Manufacturer 1 K970088 1 RIWO Drive Generator w/ Footswitch, Mator Handles & Single Use Rotary Blades & Abraders 1 Richard Wolf GmbH Lz_ 2 I _12 _ 1… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080617 | Power Drive ART1 2304 with Motor Handles, Tools and Accessories | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2015 | Class II | Z-0791-2016 | Process control | 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 | Process control | 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 | Process control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 9.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080617 (Richard Wolf Medical Instruments Corp., 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K970088.
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 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…
Read the full statement (115 words)
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,
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984304: Riwo Drive Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984304
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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