510(k) · Cleared
ClearedHydrocision Arthojet System with Cautery and Turboburr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · HRX Arthroscope
Cleared on Apr 3, 2002 as substantially equivalent to K002764 (Hydrocision, Inc., 2000) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it.
- Decided
- Apr 3, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002764 (2000). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002764 Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc. · 2000
- This deviceK020688 Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK032529 Hydrocision Arthrojet System with Cautery, Turboburr and Curette…Hydrocision, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 5 of its ownK041233 Arthrojet XTHydrocision, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK122861 XTOOLOuroboros Medical · 2012
- Descendant · 4 generations on · 0 of its ownK213978 TELIGEN SystemMedos International SARL · 2022
- Descendant · 3 generations on · 0 of its ownK200729 HydroCision SpineJet SystemHydrocision, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032529Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc. · 2003 · cites it directly6descendants
- K041233Arthrojet XTHydrocision, Inc. · 2004 · 2 generations on5descendants
- K122861XTOOLOuroboros Medical · 2012 · 3 generations on1descendant
- K213978TELIGEN SystemMedos International SARL · 2022 · 4 generations on0descendants
- K200729HydroCision SpineJet SystemHydrocision, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002764 | Hydrocision Arthrojet System with Cautery and Burr | Hydrocision, Inc. | 2000 | — |
| 0 (this device) | K020688 | Hydrocision Arthojet System with Cautery and Turboburr | Hydrocision, Inc. | 2002 | — |
| +1 | K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models… | Hydrocision, Inc. | 2003 | 2 |
| +2 | K041233 | Arthrojet XT | Hydrocision, Inc. | 2004 | — |
| +3 | K122861 | XTOOL | Ouroboros Medical | 2012 | — |
| +4 | K213978 | TELIGEN System | Medos International SARL | 2022 | — |
| +3 | K200729 | HydroCision SpineJet System | Hydrocision, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K002764 | Hydrocision Arthrojet System with Cautery and BurrSummary page 1…e modified HydroCision ArthroJet System with Cautery and TurboBurr is substantially equivalent in intended use to the HydroCision ArthroJet System with Cautery and Burr (K002764) and the Anspach eMax Drill (K011444). 4. Device Description The HydroCision ArthroJet System with Cautery and TurboBurr consis… | 2000 |
| * | K011444 | Anspach Emax Drill SystemSummary page 1…em with Cautery and TurboBurr is substantially equivalent in intended use to the HydroCision ArthroJet System with Cautery and Burr (K002764) and the Anspach eMax Drill (K011444). 4. Device Description The HydroCision ArthroJet System with Cautery and TurboBurr consists of the reusable power control unit… | 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?
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 HydroCision ArthroJet System with Cautery and TurboBurr is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.
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/K020688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020688: Hydrocision Arthojet System with Cautery and Turboburr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020688
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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