510(k) · Cleared
ClearedJoimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys Laminoscope/Multiscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joimax GmbH · HRX Arthroscope
Cleared on Aug 12, 2005 after a 37-day review. The FDA summary names its predicate without a number. 76 later devices descend from it.
- Decided
- Aug 12, 2005
- Review
- 37 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
76 later devices descend from it, 8 citing it directly.
- This deviceK051827 Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope…Joimax GmbH · 2005
- Descendant · cites it directly · 37 of its ownK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · 2 generations on · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
- Descendant · 3 generations on · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · 4 generations on · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 5 generations on · 31 of its ownK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · cites it directly37descendants
- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · 2 generations on36descendants
- K152204VS3-IR systemVisionsense, Ltd. · 2015 · 3 generations on34descendants
- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 4 generations on32descendants
- K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 5 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051827 | Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys… | Joimax GmbH | 2005 | — |
| +1 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +2 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +3 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +4 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +5 | K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | — | Richard Wolf Discoscope with Panoview Plus Optics Named without a submission number | |
| * | — | Richard Wolf YESS Named without a submission number | |
| * | — | Endius Spine Endoscope Named without a submission number | |
| * | — | Pollux Arthroscope Named without a submission number |
What descends from it? (76)
See all 768 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082355 | Visionsense Stereoscopic Vision System | 2008 | 37 |
| K061246 | Endoscopic Spine System | 2006 | 25 |
| K130778 | Discoscopes, Cervical Endoscopes | 2014 | 14 |
| K083552 | Maxmorespine Tom Stick | 2009 | 5 |
| K141326 | Needle View CH Scope Kits | 2014 | 3 |
| K090132 | Maxmorespine Spinal System | 2009 | 1 |
| K121261 | Asap Muitiscope | 2013 | 0 |
| K121482 | Instrument System for Endoscopic Spinal Surgery | 2012 | 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?
- Of its descendants, K082355 (Visionsense, Ltd., 2008) has gone furthest, with 37 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 THESSYS Multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051827: Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys Laminoscope/Multiscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051827
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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