# K190363: Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Feb 21, 2020 after 371 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K203207: Omnia Medical TiBrid-SA (2020), 1 descendant of its own
- K240623: Omnia Medical TiBrid™-SA System (2024), 0 descendants of its own

## Indications for use
The Omnia Medical TiBrid™ Cervical Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels within the cervical spine at disc levels from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have had at least six weeks of non-operative treatment prior to treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. The Omnia Medical TiBrid™ ALIF, PLIF, TLIF and Lateral Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had at least six months of non-operative treatment prior to treatment with intervertebral cages. This device is intended for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Source page: https://510kreport.com/device/K190363
Methodology: https://510kreport.com/methodology