510(k) · Cleared
ClearedT2 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Sep 21, 2009 as substantially equivalent to K082112 (Medtronic Sofamor Danek, 2008) and 1 other predicate after an 89-day review. Its family tree reaches back 10 generations to 2001. 51 later devices descend from it.
- Decided
- Sep 21, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K003155 (2001). 20 ancestors in all, the oldest K841189 (1984). 51 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 6 generations between
- 3 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
- This deviceK091883 T2 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
- Descendant · cites it directly · 49 of its ownK100976 T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 2 generations on · 47 of its ownK173125 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
- Descendant · 2 generations on · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 3 generations on · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 4 generations on · 21 of its ownK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations backK012254 VBROsteotech, Inc. · 2001
- 8 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 5 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
- This deviceK091883 T2 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · cites it directly49descendants
- K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017 · 2 generations on47descendants
- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 2 generations on28descendants
- K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 3 generations on27descendants
- K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −9 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −8 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −5 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −1 | K063491 | T2 Sceptor Spinal System | Medtronic Sofamor Danek | 2007 | — |
| 0 (this device) | K091883 | T2 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | — |
| +1 | K100976 | T2 XVBR 1.5 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +2 | K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek | 2017 | — |
| +2 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +3 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +4 | K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 0 |
| 2026 | 14 | 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? (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 |
|---|---|---|---|
| * | K082112 | T2 XVBR Spinal SystemSummary page 2…ded which demonstrated that the T2TM Spinal System components are substantially equivalent to previously cleared devices such as the T2 XVBR TM Spinal System K082112 (SE 08/27/2008) and the T2 SCEPTORTm·Spinal System K063491 (SE 3/5/2007). ©2009 Medtronic Sofamor Danek… | 2008 |
| * | K063491 | T2 Sceptor Spinal SystemSummary page 2…ts are substantially equivalent to previously cleared devices such as the T2 XVBR TM Spinal System K082112 (SE 08/27/2008) and the T2 SCEPTORTm·Spinal System K063491 (SE 3/5/2007). ©2009 Medtronic Sofamor Danek DEPARTMENT OFHEALTH&HUMAN SERVICES… | 2007 |
What descends from it? (51)
See all 513 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K100976 (Medtronic Sofamor Danek USA, Inc., 2010) has gone furthest, with 49 descendants of its own.
- 1 other device also cites its predicate K082112.
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. 2009, 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 T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), The T2TM XVBR system consists of end caps which must be attached to a T2 XVBRTM expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTORTM components also serve as a…
Read the full statement (179 words)
The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), The T2TM XVBR system consists of end caps which must be attached to a T2 XVBRTM expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTORTM components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTORTM end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBRTm and T2 SCEPTOR TM ) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE iFM Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE TM Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended-to be used with allograft and/or autograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091883: T2 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091883
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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