510(k) · Cleared
Clearedmaxmorespine Bipolar Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoogland Spine Products, GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 23, 2022 as substantially equivalent to K161378 (Joimax GmbH, 2016) after a 429-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 23, 2022
- Review
- 429 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931338 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK931338 16 Electrodes (Blade, Ball, Needle & Loop)Aaron Medical Industries · 1994
- 2 generations backK014201 Aaron Reusable Electrosurgical ElectrodeAaron Medical Industries · 2002
- 1 generation backK161378 joimax Electrosurgical InstrumentsJoimax GmbH · 2016
- This deviceK211173 maxmorespine Bipolar ElectrodesHoogland Spine Products, GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931338 | 16 Electrodes (Blade, Ball, Needle & Loop) | Aaron Medical Industries | 1994 | — |
| −2 | K014201 | Aaron Reusable Electrosurgical Electrode | Aaron Medical Industries | 2002 | — |
| −1 | K161378 | joimax Electrosurgical Instruments | Joimax GmbH | 2016 | — |
| 0 (this device) | K211173 | maxmorespine Bipolar Electrodes | Hoogland Spine Products, GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K161378 | joimax Electrosurgical InstrumentsSummary page 4…Accessories (21 CFR 878.4400) Regulatory Class: II Product Code: GEI III. PREDICATE DEVICE joimax Electrosurgical Instruments, K161378 IV. DEVICE DESCRIPTION Design Characteristics maxmorespine Bipolar Electrodes are designed with a rounded distal end, an ergono… | 2016 |
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 28 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The maxmorespine Bipolar Electrodes are indicated for the coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The maxmorespine Bipolar Electrodes have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211173: maxmorespine Bipolar Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211173
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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