# K061524: Iss Integrated Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Sep 26, 2006 after 116 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Integrated Spine System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-SI vertebral joint in skeletally mature patients receiving fusion b.utogenonrhrof4~aa.hav/ng implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass. Use of a rod and ileo-sacral screw fixation system, TI-S1, the lumbar screws and rods will assist in arthrodesis or fusion of the lumbar spine. The indications for use are: 1. Spondylolisthesis 2. Spinal Fractures 3. Spinal Stenosis 4. Deformities (Idiopathic Scoliosis, Adult Kyphosis, Lordosis) 5. Pseudarthrosis of previous fusion 6. Instability caused by Trauma or Tumors 7. Revision of previously failed fusion surgery 8. Degenerative Disk Disease 9. Stabilization after Osteotomy

Source page: https://510kreport.com/device/K061524
Methodology: https://510kreport.com/methodology