510(k) · Cleared
ClearedArthrojet XT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · HRX Arthroscope
Cleared on Jul 28, 2004 as substantially equivalent to K032529 (Hydrocision, Inc., 2003) after a 79-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.
- Decided
- Jul 28, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002764 (2000). 4 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK002764 Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc. · 2000
- 2 generations backK020688 Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
- 1 generation backK032529 Hydrocision Arthrojet System with Cautery, Turboburr and Curette…Hydrocision, Inc. · 2003 · Recalled
- This deviceK041233 Arthrojet XTHydrocision, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK122861 XTOOLOuroboros Medical · 2012
- Descendant · 2 generations on · 0 of its ownK213978 TELIGEN SystemMedos International SARL · 2022
- Descendant · cites it directly · 0 of its ownK200729 HydroCision SpineJet SystemHydrocision, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK190804 HydroCision TenJet DeviceHydrocision, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK090303 Xtend-ST Nucleus Removal System, Model 9004Corespine Technologies, LLC · 2009
Most influential descendants
Showing 5 of 5 · See all- K122861XTOOLOuroboros Medical · 2012 · cites it directly1descendant
- K213978TELIGEN SystemMedos International SARL · 2022 · 2 generations on0descendants
- K200729HydroCision SpineJet SystemHydrocision, Inc. · 2020 · cites it directly0descendants
- K190804HydroCision TenJet DeviceHydrocision, Inc. · 2019 · cites it directly0descendants
- K090303Xtend-ST Nucleus Removal System, Model 9004Corespine Technologies, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002764 | Hydrocision Arthrojet System with Cautery and Burr | Hydrocision, Inc. | 2000 | — |
| −2 | 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 |
| 0 (this device) | K041233 | Arthrojet XT | Hydrocision, Inc. | 2004 | — |
| +1 | K122861 | XTOOL | Ouroboros Medical | 2012 | — |
| +2 | K213978 | TELIGEN System | Medos International SARL | 2022 | — |
| +1 | K200729 | HydroCision SpineJet System | Hydrocision, Inc. | 2020 | — |
| +1 | K190804 | HydroCision TenJet Device | Hydrocision, Inc. | 2019 | — |
| +1 | K090303 | Xtend-ST Nucleus Removal System, Model 9004 | Corespine Technologies, LLC | 2009 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Summary page 1…Device and Accessories 3. Identification of Legally Marketed Device HydroCision ArthroJet with Cautery, TurboBurr and Curette, K032529 4. Device Description The HydroCision ArthroJet System with Cautery, TurboBurr and Curette employs two basic syste… | 2003 |
What descends from it? (5)
4 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 4 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K122861 (Ouroboros Medical, 2012) has gone furthest, with 1 descendant of its own.
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/K041233 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041233: Arthrojet XT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041233
Report an extraction error
Are you the manufacturer?
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