510(k) · Cleared
ClearedT2 Sceptor 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 Mar 5, 2007 as substantially equivalent to K052931 (Medtronic Sofamor Danek, 2005) and 2 other predicates after a 108-day review. Its family tree reaches back 9 generations to 2001. 53 later devices descend from it.
- Decided
- Mar 5, 2007
- Review
- 108 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K003155 (2001). 18 ancestors in all, the oldest K841189 (1984). 53 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations between
- 3 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- This deviceK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 51 of its ownK091883 T2 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
- Descendant · cites it directly · 50 of its ownK071033 T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 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 · 3 generations on · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations backK012254 VBROsteotech, Inc. · 2001
- 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 4 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- This deviceK063491 T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · cites it directly51descendants
- K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007 · cites it directly50descendants
- K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 2 generations on49descendants
- K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017 · 2 generations on47descendants
- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −8 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −7 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −4 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| 0 (this device) | K063491 | T2 Sceptor Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K091883 | T2 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | — |
| +1 | K071033 | T2 XVBR Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K100976 | T2 XVBR 1.5 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +2 | K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek | 2017 | — |
| +3 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K052931 | Modification to Verte-Stack Spinal SystemSummary page 2…s demonstrated that the T2TM SCEPTORTM Spinal System is substantially equivalent to similar previously cleared devices such as the VERTE-STACK®) Spinal System (K052931, SE 11/16/05 and K060719, SE 04/14/06) as well as the PYRAMESH-C Spinal System (KO011406, SE 12(27/01). *… | 2005 |
| * | K060719 | Modification to Verte-Stack Spinal SystemSummary page 2…2TM SCEPTORTM Spinal System is substantially equivalent to similar previously cleared devices such as the VERTE-STACK®) Spinal System (K052931, SE 11/16/05 and K060719, SE 04/14/06) as well as the PYRAMESH-C Spinal System (KO011406, SE 12(27/01). * ,1..,/ DEPARTMENTOFH… | 2006 |
| * | K011406 | Spinal Mesh SystemSummary page 2…r previously cleared devices such as the VERTE-STACK®) Spinal System (K052931, SE 11/16/05 and K060719, SE 04/14/06) as well as the PYRAMESH-C Spinal System (KO011406, SE 12(27/01). * ,1..,/ DEPARTMENTOFHEALTH&HUMANSERVICES Publ… | 2001 |
What descends from it? (53)
See all 532 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.
- None of the 18 ancestors has a recall.
- Of its descendants, K091883 (Medtronic Sofamor Danek USA, Inc., 2009) has gone furthest, with 51 descendants of its own.
- 7 other devices also cite its predicate K052931.
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 SCEPTORTh Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 SCEPTORTM Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically…
Read the full statement (127 words)
The T2TM SCEPTORTh Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 SCEPTORTM Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTORTh device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOKTM CLASSIC Spinal System, the VANTAGETM Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2TM SCEPTORTh device is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063491: T2 Sceptor 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/K063491
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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