# K141557: Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy  Device - Lumbar

- Pathway: 510(k) (Traditional)
- Applicant: Gallini Medical Devices, Srl
- Decided: Dec 8, 2014 after 179 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K844131 (1984). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032473: Dekompressor Percutaneous Discectomy Probe, Stryker Instruments (2003) Summary page 4.

## Most influential descendants
- K180315: Diskom (2018), 0 descendants of its own

## Recalls of this device
- May 17, 2021 · Class II · Z-0146-2022: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
- May 17, 2021 · Class II · Z-0145-2022: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
- May 17, 2021 · Class II · Z-0144-2022: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

## Indications for use
The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

Source page: https://510kreport.com/device/K141557
Methodology: https://510kreport.com/methodology