510(k) · Cleared
Recalled · Class II · 2024Omnia Medical TiBrid-SA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnia Medical, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 23, 2020 as substantially equivalent to K170157 (Globus Medical, Inc., 2017) and 1 other predicate after a 54-day review. Its family tree reaches back 19 generations to 1984. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 23, 2020
- Review
- 54 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 19 generations to K841189 (1984). 171 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK160597 INDEPENDENCE MIS SpacersGlobus Medical, Inc. · 2016
- 1 generation backK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
- This deviceK203207 Omnia Medical TiBrid-SAOmnia Medical, LLC · 2020
- Descendant · cites it directly · 0 of its ownK240623 Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC · 2024
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 6 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 5 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 4 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK160597 INDEPENDENCE MIS SpacersGlobus Medical, Inc. · 2016
- 1 generation backK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
- This deviceK203207 Omnia Medical TiBrid-SAOmnia Medical, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −6 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −5 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −4 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −3 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −2 | K160597 | INDEPENDENCE MIS Spacers | Globus Medical, Inc. | 2016 | — |
| −1 | K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | 2017 | — |
| 0 (this device) | K203207 | Omnia Medical TiBrid-SA | Omnia Medical, LLC | 2020 | — |
| +1 | K240623 | Omnia Medical TiBrid™-SA System | Omnia Medical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 22 | 0 |
| 2005 | 14 | 0 |
| 2006 | 9 | 0 |
| 2007 | 10 | 0 |
| 2008 | 19 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170157 | INDEPENDENCE® SpacersSummary page 4…Class II Reviewing Panel: Orthopedic Product Code: OVD Primary Predicate Device: Globus Medical Independence MIS® Spacer (K170157) Additional Predicates: Omnia TiBrid™-A Intervertebral Fusion Device (K190363) Device Description: The Omnia Medica… | 2017 |
| * | K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical…Summary page 4…OVD Primary Predicate Device: Globus Medical Independence MIS® Spacer (K170157) Additional Predicates: Omnia TiBrid™-A Intervertebral Fusion Device (K190363) Device Description: The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system used in the spine t… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240623 | Omnia Medical TiBrid™-SA System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2024 | Class II | Z-2557-2025 | Device Design | Failure of fusion system instruments in the field. |
| Jul 15, 2024 | Class II | Z-2556-2025 | Device Design | Failure of fusion system instruments in the field. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 171 ancestors have a recall of any class.
- Of its descendants, K240623 (Omnia Medical, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K170157.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
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…
Read the full statement (112 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203207: Omnia Medical TiBrid-SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203207
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026