510(k) · Cleared
ClearedArthrex Spine Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HRX Arthroscope
Cleared on May 16, 2025 as substantially equivalent to K130778 (Rz Medizintechnik GmbH, 2014) after a 176-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 16, 2025
- Review
- 176 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953484 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK953484 Pollux OA/Pollux 30A/Pollux 70APollux Endoscopy, Inc. · 1995
- 2 generations backK082841 Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009
- 1 generation backK130778 Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
- This deviceK243602 Arthrex Spine EndoscopeArthrex, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953484 | Pollux OA/Pollux 30A/Pollux 70A | Pollux Endoscopy, Inc. | 1995 | — |
| −2 | K082841 | Spinal Foraminoscope | Blazejewski Medi-Tech GmbH | 2009 | — |
| −1 | K130778 | Discoscopes, Cervical Endoscopes | Rz Medizintechnik GmbH | 2014 | — |
| 0 (this device) | K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K130778 | Discoscopes, Cervical EndoscopesSummary page 5…cope and accessories Product Code HRX, GCJ Common Name Spinal Endoscope Regulatory Class Class II Primary Predicate K130778 RZ Medizintechnik Cervical Endoscopes Device Purpose of Submission This Traditional 510(k) premarket notification is submitted… | 2014 |
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 4 companies; a new generation was cleared every 11.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K130778.
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 Arthrex Spine Endoscope is indicated for use to provide visualization during spinal endoscopic procedures and minimally invasive surgery.
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/K243602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243602: Arthrex Spine Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243602
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