510(k) · Cleared
ClearedVax-D Genesis G2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vax-D Medical Technologies, LLC · ITH Equipment, Traction, Powered
Cleared on Oct 5, 2007 as substantially equivalent to K053503 (Vax-D Medical Technologies USA, L.C., 2005) and 3 other predicates after a 144-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Oct 5, 2007
- Review
- 144 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K894435 (1989). 5 ancestors in all, the oldest K844385 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 2 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 1 generation backK053503 Vax-D Genesis System (Therapeutic Table)Vax-D Medical Technologies USA, L.C. · 2005
- This deviceK071347 Vax-D Genesis G2 SystemVax-D Medical Technologies, LLC · 2007
- Descendant · cites it directly · 0 of its ownK103248 Integrity Spinal Care SystemIntegra Life Sciences · 2011
Most influential descendants
Showing 1 of 1 · See all- K103248Integrity Spinal Care SystemIntegra Life Sciences · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −2 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −1 | K053503 | Vax-D Genesis System (Therapeutic Table) | Vax-D Medical Technologies USA, L.C. | 2005 | — |
| 0 (this device) | K071347 | Vax-D Genesis G2 System | Vax-D Medical Technologies, LLC | 2007 | — |
| +1 | K103248 | Integrity Spinal Care System | Integra Life Sciences | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 ITH? 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 ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K053503 | Vax-D Genesis System (Therapeutic Table)Summary page 1…ODE: 89 ITH D PANEL CODE: 87OR 6. PREDICATE DEVICE(s): VAX-D Genesis System K053503 VAX-D Therapeutic Table K951622 3D Activetrac… | 2005 |
| * | K951622 | Vax-D Therapeutic TableSummary page 1…87OR 6. PREDICATE DEVICE(s): VAX-D Genesis System K053503 VAX-D Therapeutic Table K951622 3D Activetrac K001712 Henley Tru-Trac 401… | 1996 |
| * | K001712 | 3D ActivetracSummary page 1…K053503 VAX-D Therapeutic Table K951622 3D Activetrac K001712 Henley Tru-Trac 401 K844385 7. DEVICE DESCRIPTION The VAX-D Genesis G2 is… | 2000 |
| * | K844385 | Escotek Est Trac 401Summary page 1…K951622 3D Activetrac K001712 Henley Tru-Trac 401 K844385 7. DEVICE DESCRIPTION The VAX-D Genesis G2 is designed to apply distraction tensions to the patient's lumbar and… | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103248 | Integrity Spinal Care System | 2011 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103248 (Integra Life Sciences, 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K053503.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, 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 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the spine that generate localized pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs as well as those with acute facet problems and sciatica.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071347: Vax-D Genesis G2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071347
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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