# K212612: Omnia Medical TiBrid-SC

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Nov 15, 2022 after 455 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K003155 (2001). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System, SeaSpine Orthopedics Corporation (2017) Summary page 4.

## Indications for use
The TiBridTm-SC standalone cervical intervertebral fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. The implants are to be used with autogenous bone graft and/or allograft comprised ofcancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks ofnon-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.

Source page: https://510kreport.com/device/K212612
Methodology: https://510kreport.com/methodology