510(k) · Cleared
ClearedT2 XVBR Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MQP Spinal Vertebral Body Replacement Device
Cleared on Aug 14, 2007 as substantially equivalent to K063491 (Medtronic Sofamor Danek, 2007) and 5 other predicates after a 124-day review. Its family tree reaches back 10 generations to 2001. 50 later devices descend from it.
- Decided
- Aug 14, 2007
- Review
- 124 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K003155 (2001). 34 ancestors in all, the oldest K792352 (1979). 50 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 deviceK071033 T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 49 of its ownK100976 T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · cites it directly · 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 · cites it directly · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 2 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 deviceK071033 T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · cites it directly49descendants
- K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017 · cites it directly47descendants
- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 2 generations on28descendants
- K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019 · cites it directly27descendants
- K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 2 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) | K071033 | T2 XVBR Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K100976 | T2 XVBR 1.5 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +1 | K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek | 2017 | — |
| +2 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +1 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +2 | 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 |
|---|---|---|
| 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 |
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 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K063491 | T2 Sceptor Spinal SystemSummary page 2…ich demonstrated that the T2TM Spinal System components are substantially equivalent to previously cleared devices such as the T2TM SCEPTORTm Spinal System K063491 (SE 3/5/2007), the VERTE-STACK®) Spinal System K052931 (SE 11/16/2005), the VERTE-SPANTm Spinal System K024049 (SE 2/… | 2007 |
| * | K052931 | Modification to Verte-Stack Spinal SystemSummary page 2…ts are substantially equivalent to previously cleared devices such as the T2TM SCEPTORTm Spinal System K063491 (SE 3/5/2007), the VERTE-STACK®) Spinal System K052931 (SE 11/16/2005), the VERTE-SPANTm Spinal System K024049 (SE 2/26/2003), the XENTURETm Anterior Cervical Plate System… | 2005 |
| * | K024049 | Verte-Span Spinal SystemSummary page 2…vices such as the T2TM SCEPTORTm Spinal System K063491 (SE 3/5/2007), the VERTE-STACK®) Spinal System K052931 (SE 11/16/2005), the VERTE-SPANTm Spinal System K024049 (SE 2/26/2003), the XENTURETm Anterior Cervical Plate System K042922 (SE 11/19/2004), the CD HORIZON® Spinal System K992928… | 2003 |
| * | K042922 | Venture Anterior Cervical Plating SystemSummary page 2…VERTE-STACK®) Spinal System K052931 (SE 11/16/2005), the VERTE-SPANTm Spinal System K024049 (SE 2/26/2003), the XENTURETm Anterior Cervical Plate System K042922 (SE 11/19/2004), the CD HORIZON® Spinal System K992928 (SE 9/21/1999) and K043488 (SE 3/22/2005).… | 2004 |
| * | K992928 | CD Horizon Spinal SystemSummary page 2…), the VERTE-SPANTm Spinal System K024049 (SE 2/26/2003), the XENTURETm Anterior Cervical Plate System K042922 (SE 11/19/2004), the CD HORIZON® Spinal System K992928 (SE 9/21/1999) and K043488 (SE 3/22/2005).… | 1999 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 2…System K024049 (SE 2/26/2003), the XENTURETm Anterior Cervical Plate System K042922 (SE 11/19/2004), the CD HORIZON® Spinal System K992928 (SE 9/21/1999) and K043488 (SE 3/22/2005). QQUQQ&a === Page… | 2005 |
What descends from it? (50)
See all 503 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 6 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 34 ancestors has a recall of any class.
- 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 K063491.
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. 2007, 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 (T l-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of a series of end caps, baskets, and covers 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…
Read the full statement (183 words)
The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T l-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of a series of end caps, baskets, and covers 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 SCEPTORTM) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE IMM Anterior Fixation System, the DYNALOK 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 bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071033: T2 XVBR 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/K071033
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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