510(k) · Cleared
ClearedHydroCision SpineJet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · HRX Arthroscope
Cleared on Apr 16, 2020 as substantially equivalent to K041233 (Hydrocision, Inc., 2004) after a 27-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Apr 16, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002764 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK200729 HydroCision SpineJet SystemHydrocision, Inc. · 2020
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) | K200729 | HydroCision SpineJet System | Hydrocision, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K041233 | Arthrojet XTSummary page 5…HydroCision SpineJet System- Special 510(k) 5.6. Predicate Device: HydroCision ArthroJet with Cautery, TurboBurr and Curette (K041233). HydroCision ArthroJet System has been rebranded to HydroCision SpineJet System. The purpose of this Special 510(k… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 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. 2020, 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 HydroCision SpineJet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive spinal surgeries.
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/K200729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200729: HydroCision SpineJet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200729
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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