510(k) · Cleared
ClearedIntegrity Spinal Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Life Sciences · ITH Equipment, Traction, Powered
Cleared on Apr 5, 2011 as substantially equivalent to K071347 (Vax-D Medical Technologies, LLC, 2007) and 1 other predicate after a 153-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Apr 5, 2011
- Review
- 153 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894435 (1989). 7 ancestors in all, the oldest K844385 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 3 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 2 generations backK053503 Vax-D Genesis System (Therapeutic Table)Vax-D Medical Technologies USA, L.C. · 2005
- 1 generation backK071347 Vax-D Genesis G2 SystemVax-D Medical Technologies, LLC · 2007
- This deviceK103248 Integrity Spinal Care SystemIntegra Life Sciences · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −3 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −2 | K053503 | Vax-D Genesis System (Therapeutic Table) | Vax-D Medical Technologies USA, L.C. | 2005 | — |
| −1 | K071347 | Vax-D Genesis G2 System | Vax-D Medical Technologies, LLC | 2007 | — |
| 0 (this device) | 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 |
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K071347 | Vax-D Genesis G2 SystemSummary page 1…tion ______________Numbher Vax-D Genesis G2 Vax-D-Medical Class WlITH- K07 1347 System Technologies LLC _________ DRX5000 Axiom USA Inc. Class I/ITH… | 2007 |
| * | K023160 | DRX5000Summary page 1…K07 1347 System Technologies LLC _________ DRX5000 Axiom USA Inc. Class I/ITH K023 160 The rationale of declaring the Integrity Spinal Care System substantially equivalent to the above two predicate devices are base… | 2002 |
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 22 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Integrity Spinal Care System provides a program of treatments for relief from pain for those patients suffering with low back pain or neck pain. Each treatment consists of a physician prescribed treatment period on the Integrity Spinal Care System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that-May be treated include:neck gain…
Read the full statement (105 words)
The Integrity Spinal Care System provides a program of treatments for relief from pain for those patients suffering with low back pain or neck pain. Each treatment consists of a physician prescribed treatment period on the Integrity Spinal Care System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that-May be treated include:neck gain and back pain assocated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica, It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103248: Integrity Spinal Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103248
Report an extraction error
Are you the manufacturer?
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