510(k) · Cleared
Recalled · 2006Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · HRX Arthroscope
Cleared on Sep 16, 2003 as substantially equivalent to K020688 (Hydrocision, Inc., 2002) after a 32-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 16, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002764 (2000). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002764 Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc. · 2000
- 1 generation backK020688 Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
- This deviceK032529 Hydrocision Arthrojet System with Cautery, Turboburr and Curette…Hydrocision, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK041233 Arthrojet XTHydrocision, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK122861 XTOOLOuroboros Medical · 2012
- Descendant · 3 generations on · 0 of its ownK213978 TELIGEN SystemMedos International SARL · 2022
- Descendant · 2 generations on · 0 of its ownK200729 HydroCision SpineJet SystemHydrocision, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK190804 HydroCision TenJet DeviceHydrocision, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041233Arthrojet XTHydrocision, Inc. · 2004 · cites it directly5descendants
- K122861XTOOLOuroboros Medical · 2012 · 2 generations on1descendant
- K213978TELIGEN SystemMedos International SARL · 2022 · 3 generations on0descendants
- K200729HydroCision SpineJet SystemHydrocision, Inc. · 2020 · 2 generations on0descendants
- K190804HydroCision TenJet DeviceHydrocision, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002764 | Hydrocision Arthrojet System with Cautery and Burr | Hydrocision, Inc. | 2000 | — |
| −1 | K020688 | Hydrocision Arthojet System with Cautery and Turboburr | Hydrocision, Inc. | 2002 | — |
| 0 (this device) | K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models… | Hydrocision, Inc. | 2003 | — |
| +1 | K041233 | Arthrojet XT | Hydrocision, Inc. | 2004 | — |
| +2 | K122861 | XTOOL | Ouroboros Medical | 2012 | — |
| +3 | K213978 | TELIGEN System | Medos International SARL | 2022 | — |
| +2 | K200729 | HydroCision SpineJet System | Hydrocision, Inc. | 2020 | — |
| +2 | K190804 | HydroCision TenJet Device | Hydrocision, Inc. | 2019 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K020688 | Hydrocision Arthojet System with Cautery and TurboburrSummary page 1…with Cautery, TurboBurr, and Curette is substantially equivalent in intended use to the HydroCision ArthroJet System with Cautery and TurboBurr (K020688). 4. Device Description The Hydrocision ArthroJet System with Cautery, TurboBurr, and Curette consists of the… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041233 | Arthrojet XT | 2004 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2006 | Not classified | Z-0124-2007 | Process change control | Distal tip may become detached from the device |
| Sep 7, 2006 | Not classified | Z-0123-2007 | Process change control | Distal tip may become detached from the device |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K041233 (Hydrocision, Inc., 2004) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K020688.
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, TurboBurr and Curette 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 minimally invasive spinal surgeries and small and large joint arthroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032529: Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032529
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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