510(k) · Cleared
ClearedMaxmorespine Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoogland Spine Products, GmbH · HRX Arthroscope
Cleared on Jun 9, 2009 as substantially equivalent to K051827 (Joimax GmbH, 2005) and 2 other predicates after a 139-day review. Its family tree reaches back 4 generations to 1999. 1 later device descends from it.
- Decided
- Jun 9, 2009
- Review
- 139 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K991794 (1999). 12 ancestors in all, the oldest K941967 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- 3 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
- 2 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 1 generation backK061246 Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
- This deviceK090132 Maxmorespine Spinal SystemHoogland Spine Products, GmbH · 2009
- Descendant · cites it directly · 0 of its ownK121482 Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC · 2012
Most influential descendants
Showing 1 of 1 · See all- K121482Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991794 | Endoscopic Spinal Access System | Endius, Inc. | 1999 | — |
| −3 | K021748 | Endius Atavi System | Endius, Inc. | 2002 | — |
| −2 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −1 | K061246 | Endoscopic Spine System | Arthro Kinetics, Inc. | 2006 | — |
| 0 (this device) | K090132 | Maxmorespine Spinal System | Hoogland Spine Products, GmbH | 2009 | — |
| +1 | K121482 | Instrument System for Endoscopic Spinal Surgery | Theken Spine, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K051827 | Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys… | 2005 |
| * | K973405 | Yeung Endoscopic Spine SystemSummary page 2…ction to the following marketed products; - Joimax THESSYS Multiscope (KO51827) - Richard Wolf Yeung Endoscopic Spine System (K973405) - Arthro Kinetics' Endoscopic Spine System (K061246) 1.12 Sterilization With th… | 1998 |
| * | K061246 | Endoscopic Spine SystemSummary page 2…ESSYS Multiscope (KO51827) - Richard Wolf Yeung Endoscopic Spine System (K973405) - Arthro Kinetics' Endoscopic Spine System (K061246) 1.12 Sterilization With the exception of the Disposable 4mm Manual Bone Drill, maxMore… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K121482 (Theken Spine, LLC, 2012) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K051827.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as; arthroplasty, nucleotomy, discqectomy and foraminotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090132: Maxmorespine Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090132
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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