510(k) · Cleared
ClearedVirtu C Spinal Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Met 1 Technologies, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 9, 2016 as substantially equivalent to K112036 (X-Spine Systems, Inc., 2011) after a 147-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 9, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P980048 (2001). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 1 generation backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- This deviceK161649 Virtu C Spinal Implant SystemMet 1 Technologies, LLC · 2016
- Descendant · cites it directly · 1 of its ownK222806 Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK230851 Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −1 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| 0 (this device) | K161649 | Virtu C Spinal Implant System | Met 1 Technologies, LLC | 2016 | — |
| +1 | K222806 | Kodiak C Spinal Implant System | Met One Technologies, LLC | 2022 | — |
| +2 | K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K112036 | Calix PC Spinal Implant SystemSummary page 5…Predicate Trade or Proprietary or Model Name Manufacturer Number Type K112036 Calix™ Spinal Implant System X-Spine Systems Primary K083637 Calix™ Spinal Implant System X-… | 2011 |
| † | K083637 | Calix Spinal Implant System | 2009 |
| † | K142205 | NuVasive X-CORE (R) Expandable VBR System | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222806 | Kodiak C Spinal Implant System | 2022 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K222806 (Met One Technologies, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K112036.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
When used as an Intervertebral Body Fusion Device: The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or…
Read the full statement (200 words)
When used as an Intervertebral Body Fusion Device:
The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocortical bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.
When used as a Vertebral Body Replacement Device:
The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or tumor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161649: Virtu C Spinal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161649
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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