# K071810: Inion Spinal Graft Containment System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Jul 11, 2008 after 375 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: 4 generations back to K010911 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010911: Macropore OS Spinal System, Macropore Biosurgery, Inc. (2001) Summary page 1.
- K041105: Macropore Hydrosorb Spine System, Macropore Biosurgery, Inc. (2004) Summary page 1.
- K051821: Inion S-1 Biodegradable Anterior Cervical Fusion System, Inion, Ltd. (2005) Summary page 1.
- K010348: Tantalum Beads - Radiographic Marker, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K151360: Inion Spinal Graft Containment System (2015), 0 descendants of its own

## Indications for use
Inion Spinal Graft Containment 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. The device is not intended for load bearing indications.

Source page: https://510kreport.com/device/K071810
Methodology: https://510kreport.com/methodology