510(k) · Cleared
ClearedXTOOL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ouroboros Medical · HRX Arthroscope
Cleared on Dec 7, 2012 as substantially equivalent to K041233 (Hydrocision, Inc., 2004) and 1 other predicate after an 80-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Dec 7, 2012
- Review
- 80 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002764 (2000). 6 ancestors in all, the oldest K972768 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002764 Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc. · 2000
- 3 generations backK020688 Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
- 2 generations backK032529 Hydrocision Arthrojet System with Cautery, Turboburr and Curette…Hydrocision, Inc. · 2003 · Recalled
- 1 generation backK041233 Arthrojet XTHydrocision, Inc. · 2004
- This deviceK122861 XTOOLOuroboros Medical · 2012
- Descendant · cites it directly · 0 of its ownK213978 TELIGEN SystemMedos International SARL · 2022
Most influential descendants
Showing 1 of 1 · See all- K213978TELIGEN SystemMedos International SARL · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002764 | Hydrocision Arthrojet System with Cautery and Burr | Hydrocision, Inc. | 2000 | — |
| −3 | K020688 | Hydrocision Arthojet System with Cautery and Turboburr | Hydrocision, Inc. | 2002 | — |
| −2 | K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models… | Hydrocision, Inc. | 2003 | 2 |
| −1 | K041233 | Arthrojet XT | Hydrocision, Inc. | 2004 | — |
| 0 (this device) | K122861 | XTOOL | Ouroboros Medical | 2012 | — |
| +1 | K213978 | TELIGEN System | Medos International SARL | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K041233 | Arthrojet XTSummary page 2…OMY Device is substantially equivalent in intended use and technology to the currently marketed predicate devices the HydroCision Arthrojet/Spineiet handpiece (K04 1233) and the Blackstone Medical Inc. Laparoscopic Disc Removal System (K972768). Both the Application device and the predic… | 2004 |
| * | K972768 | Blackstone Medical, Inc. Laparoscopic Disc Removal SystemSummary page 2…currently marketed predicate devices the HydroCision Arthrojet/Spineiet handpiece (K04 1233) and the Blackstone Medical Inc. Laparoscopic Disc Removal System (K972768). Both the Application device and the predicate devices provide a means to cut soft tissue, remove cartilage, and aspirate t… | 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 |
|---|---|---|---|
| K213978 | TELIGEN System | 2022 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K213978 (Medos International SARL, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K041233.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 XTooTM Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122861: XTOOL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122861
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