# K203207: Omnia Medical TiBrid-SA

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Dec 23, 2020 after 54 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K841189 (1984). 171 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170157: INDEPENDENCE® Spacers, Globus Medical, Inc. (2017) Summary page 4.
- 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, Omnia Medical, LLC (2020) Summary page 4.

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

## Recalls of this device
- Jul 15, 2024 · Class II · Z-2557-2025: Failure of fusion system instruments in the field.
- Jul 15, 2024 · Class II · Z-2556-2025: Failure of fusion system instruments in the field.

## 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 provided.

Source page: https://510kreport.com/device/K203207
Methodology: https://510kreport.com/methodology