510(k) · Cleared
ClearedT2 XVBR Spinal System, T2 Altitude Expandable Corpectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Sep 23, 2013 as substantially equivalent to K091883 (Medtronic Sofamor Danek USA, Inc., 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Sep 23, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K003155 (2001). 38 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
- 2 generations backK071033 T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007
- 1 generation backK100976 T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- This deviceK131888 T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc. · 2013
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
- 2 generations backK071033 T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007
- 1 generation backK100976 T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- This deviceK131888 T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K063491 | T2 Sceptor Spinal System | Medtronic Sofamor Danek | 2007 | — |
| −2 | K071033 | T2 XVBR Spinal System | Medtronic Sofamor Danek | 2007 | — |
| −1 | K100976 | T2 XVBR 1.5 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| 0 (this device) | K131888 | T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy Device | Medtronic Sofamor Danek, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K091883 | T2 Spinal SystemSummary page 4…equivalent to and previously cleared under previous 5 10O(k) submissions such as: * T2 XVBRTM Spinal System K091883 (S.E. 09/21/2009) * T2 ALTITUDETM Expandable Corpectomy System K 100976 (S.E.… | 2009 |
| * | K100976 | T2 XVBR 1.5 Spinal SystemSummary page 4…VBRTM Spinal System K091883 (S.E. 09/21/2009) * T2 ALTITUDETM Expandable Corpectomy System K 100976 (S.E. 10/21/20 10) VII1. Discussion of Non-Clinical Testing: In accordance with FDA Guidance "Establishing Safety and… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 1 of the 38 ancestors has a recall of any class.
- 2 other devices also cite its predicate K091883.
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. 2013, 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 flTM components consist of end caps which must be attached to aT2 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 (280 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 flTM components consist of end caps which must be attached to aT2 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-CtD device to form a complete construct. Both constructs (T2 XVBRTM and 12 SCEPTQRTM) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE 11I1TM Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGETM 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.
The T'2 ALTITUDETM Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-1-5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDETM Expandable Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE@ Anterior Fixation System, the TSRH®D Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDETM Expandable Corpectomy System is intended to be used with allograft and/or autograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131888: T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131888
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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