510(k) · Cleared
ClearedSpineSite Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · HRX Arthroscope
Cleared on Jul 30, 2025 as substantially equivalent to K201134 (Arthrex, Inc., 2020) after a 387-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 30, 2025
- Review
- 387 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K950862 (1995). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 6 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 5 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 4 generations backK071756 Endohub- 1.0 Endoscopic Video Camera System with Video CapturePointe Conception Medical, Inc. · 2007
- 3 generations backK153218 Arthrex Synergy UHD4 SystemArthrex, Inc. · 2016
- 2 generations backK190645 Arthrex NanoScope SystemArthrex, Inc. · 2019
- 1 generation backK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- This deviceK241990 SpineSite Endoscope SystemHydrocision, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −6 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −5 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −4 | K071756 | Endohub- 1.0 Endoscopic Video Camera System with Video Capture | Pointe Conception Medical, Inc. | 2007 | — |
| −3 | K153218 | Arthrex Synergy UHD4 System | Arthrex, Inc. | 2016 | — |
| −2 | K190645 | Arthrex NanoScope System | Arthrex, Inc. | 2019 | — |
| −1 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K201134 | Arthrex NanoScope SystemSummary page 5…Arthroscope and accessories Classification Panel: Orthopedic Product Code: HRX Predicate Device: Arthrex Nanoscope System, K201134 Product Codes: GCJ, HRX Classifications: 876.1500 and 888.1100 P… | 2020 |
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 30 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 4 other devices also cite its predicate K201134.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 SpineSite System is intended to be used as a single-use endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures for spine applications. The device is also intended to be used as an accessory for microscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241990: SpineSite Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241990
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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