# K211173: maxmorespine Bipolar Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Hoogland Spine Products, GmbH
- Decided: Jun 23, 2022 after 429 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931338 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161378: joimax Electrosurgical Instruments, Joimax GmbH (2016) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K211173
Methodology: https://510kreport.com/methodology