# K060346: Ultrazonix Spine Minimal-Invasive Disc System

- Pathway: 510(k) (Traditional)
- Applicant: Ultrazonix Dnt AB
- Decided: Dec 22, 2006 after 315 days
- Product code: NTB (System, Ablation, Ultrasound And 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: 8 generations back to K942299 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974464: Oratec Spinecath Intradiscal Catheter, Oratec Interventions, Inc. (1998) Summary page 2.
- K993854: Ora-50 S Autotemp Electrothermal Spine System and Accessories, Oratec Interventions, Inc. (1999) Summary page 2.
- K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1, Epicor Medical, Inc. (2004) Summary page 2.

## Indications for use
The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoracic and cervical intervertebral regions of the spine and should not be used in those regions.

Source page: https://510kreport.com/device/K060346
Methodology: https://510kreport.com/methodology