# K151360: Inion Spinal Graft Containment System

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Oct 6, 2015 after 139 days
- Product code: OJB (Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010911 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071810: Inion Spinal Graft Containment System, Inion, Ltd. (2008) Summary page 5.

## Indications for use
The Inion spinal graft containment plate system, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing indications.

Source page: https://510kreport.com/device/K151360
Methodology: https://510kreport.com/methodology