# K051821: Inion S-1 Biodegradable Anterior Cervical Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Nov 25, 2005 after 143 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: 3 generations back to K010911 (2001). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- K071810: Inion Spinal Graft Containment System (2008), 1 descendant of its own
- K151360: Inion Spinal Graft Containment System (2015), 0 descendants of its own

## Indications for use
The INION S-1TM BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with traditional rigid fixation (i.e., posterior interspinous wiring), is intended for use in cervical spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing indications. The INION S_1TM BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM implants are not intended for use in and are contraindicated for: • Load bearing indications unless used in conjunction with traditional rigid fixation. • Active or potential infection. • Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse).

Source page: https://510kreport.com/device/K051821
Methodology: https://510kreport.com/methodology