# K103248: Integrity Spinal Care System

- Pathway: 510(k) (Traditional)
- Applicant: Integra Life Sciences
- Decided: Apr 5, 2011 after 153 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894435 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071347: Vax-D Genesis G2 System, Vax-D Medical Technologies, LLC (2007) Summary page 1.
- K023160: DRX5000, Axiom Usa., Inc. (2002) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K103248
Methodology: https://510kreport.com/methodology