510(k) · Cleared
ClearedOmnia Medical VBR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnia Medical, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 26, 2017 as substantially equivalent to K070381 (Theken Spine, LLC, 2007) after an 86-day review. Its family tree reaches back 8 generations to 1984. 6 later devices descend from it.
- Decided
- Oct 26, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K841189 (1984). 15 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 1 generation backK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
- This deviceK172323 Omnia Medical VBROmnia Medical, LLC · 2017
- Descendant · cites it directly · 5 of its ownK191778 Omnia Medical VBROmnia Medical, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK202637 F3D Corpectomy SystemCorelink, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
- Descendant · 2 generations on · 0 of its ownK252219 Cervical Interbody and VBR Fusion SystemSync Surgical · 2026
- Descendant · 3 generations on · 0 of its ownK232790 KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191778Omnia Medical VBROmnia Medical, LLC · 2019 · cites it directly5descendants
- K202637F3D Corpectomy SystemCorelink, LLC · 2020 · 2 generations on1descendant
- K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020 · 2 generations on1descendant
- K252219Cervical Interbody and VBR Fusion SystemSync Surgical · 2026 · 2 generations on0descendants
- K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −1 | K070381 | Theken VU Mesh VBR System | Theken Spine, LLC | 2007 | — |
| 0 (this device) | K172323 | Omnia Medical VBR | Omnia Medical, LLC | 2017 | — |
| +1 | K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019 | — |
| +2 | K202637 | F3D Corpectomy System | Corelink, LLC | 2020 | — |
| +2 | K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020 | — |
| +2 | K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026 | — |
| +3 | K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K070381 | Theken VU Mesh VBR SystemSummary page 4…060) Device Classification: Class II Reviewing Panel: Orthopedic Product Code: MQP Primary Predicate Device: Vu Mesh VBR (K070381) The predicate device has never been subject to a recall. Reference Devices: Arena-C… | 2007 |
| † | K142026 | Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device | 2014 |
| † | K142345 | Talos-C (HA) Cervical Intervertebral Body Fusion Devices | 2015 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191778 | Omnia Medical VBR | 2019 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K191778 (Omnia Medical, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K070381.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.
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/K172323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172323: Omnia Medical VBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172323
Report an extraction error
Are you the manufacturer?
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