510(k) · Cleared
ClearedUltrazonix Spine Minimal-Invasive Disc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrazonix Dnt AB · NTB System, Ablation, Ultrasound And Accessories
Cleared on Dec 22, 2006 as substantially equivalent to K974464 (Oratec Interventions, Inc., 1998) and 2 other predicates after a 315-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Dec 22, 2006
- Review
- 315 days
- Class
- Class II
- Product code
- NTB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K942299 (1995). 57 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 6 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 5 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 4 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 3 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 2 generations backK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- 1 generation backK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- This deviceK060346 Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −7 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −6 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −5 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −4 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −3 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −2 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| −1 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| 0 (this device) | K060346 | Ultrazonix Spine Minimal-Invasive Disc System | Ultrazonix Dnt AB | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 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 NTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K974464 | Oratec Spinecath Intradiscal CatheterSummary page 2…. Predicate Device(s) Device 510(k) Document ~Date"l Indication's Oratec SpineCATli K974464 3/19/1998 coagulation and Intradiscal Catheter decompr… | 1998 |
| * | K993854 | Ora-50 S Autotemp Electrothermal Spine System and AccessoriesSummary page 2…symptomatic patients with annular Oratec ORA-50 S K993854 12/6/1999 disruption of Auto Temup Electro contained hernia… | 1999 |
| * | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Summary page 2…contained herniated Thermal Spine discs System & Accessories Epicor Medical K040641 5/5/2004 For the ablation of UltraCinch Tissue cardiac ti… | 2004 |
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 11 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 57 ancestors have a recall of any class.
- 2 other devices also cite its predicate K974464.
How does its category compare?
All NTB devicesNTB System, Ablation, Ultrasound And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NTB
Too few NTB 510(k)s in any year since 2007 to give a median.
Recalls per year · NTB
No recall names NTB since 2007.
Adverse event reports per year · NTB
2in 2012
MAUDE reports naming product code NTB, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 19 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060346: Ultrazonix Spine Minimal-Invasive Disc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060346
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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