510(k) · Cleared
ClearedMiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimaging Integrated Solution, Inc (Miis) · HRX Arthroscope
Cleared on Dec 23, 2025 as substantially equivalent to K201134 (Arthrex, Inc., 2020) after an 85-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Dec 23, 2025
- Review
- 85 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 deviceK253217 MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display…Medimaging Integrated Solution, Inc (Miis) · 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) | K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet… | Medimaging Integrated Solution, Inc (Miis) | 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 6…eo Box (EVS 700) Common Name: Arthroscope Regulation Name: Arthroscope Regulation Number: 21 CFR 888.1100 Regulatory Class: Class II Product Code: HRX Predicate Device: K201134 Trade/Device Name: Arthrex NanoScope System Regulation Number: 21 CFR 876.1500 and 888.1100 Regulatory Class: Class II Product Co… | 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?
MiiS Horus Arthroscope: The MiiS Horus Arthroscope is a sterile and single-use device designed for operation with its compatible display system. It is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization of an interior cavity of the body through a surgical opening. The device is intended for use in a hospital or medical office environment and is designed for use in adults. MiiS Horus Endoscope…
Read the full statement (130 words)
MiiS Horus Arthroscope:
The MiiS Horus Arthroscope is a sterile and single-use device designed for operation with its compatible display system.
It is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization of an interior cavity of the body through a surgical opening.
The device is intended for use in a hospital or medical office environment and is designed for use in adults.
MiiS Horus Endoscope Display System -Tablet:
The MiiS Horus Endoscope Display System -Tablet is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.
MiiS Horus Endoscope Display System -Video Box:
The MiiS Horus Endoscope Display System -Video Box is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.
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/K253217 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253217: MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253217
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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