# K240623: Omnia Medical TiBrid™-SA System

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Apr 24, 2024 after 50 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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: 20 generations back to K841189 (1984). 173 ancestors in all.
No later device cites it as a predicate yet.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203207: Omnia Medical TiBrid-SA, Omnia Medical, LLC (2020) Summary page 4.
- K082926: Zuma, Model 55-XXXX/56-XXXX, Seaspine, Inc. (2008) Summary page 4.

## Indications for use
The TiBrid™-SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation. The TiBrid™-SA is a standalone device and must be used with the internal bone screws or TiBrid™-SA plate and bone screws provided.

Source page: https://510kreport.com/device/K240623
Methodology: https://510kreport.com/methodology