510(k) · Cleared
ClearedT2 STRATOSPHERE™ Expandable Corpectomy 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 Dec 20, 2017 as substantially equivalent to K100976 (Medtronic Sofamor Danek USA, Inc., 2010) and 3 other predicates after an 82-day review. Its family tree reaches back 12 generations to 2001. 47 later devices descend from it.
- Decided
- Dec 20, 2017
- Review
- 82 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K003155 (2001). 41 ancestors in all, the oldest K792352 (1979). 47 later devices descend from it, 4 citing it directly.
- 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 deviceK173125 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · cites it directly · 18 of its ownK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
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 deviceK173125 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · cites it directly28descendants
- 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
- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · 3 generations on20descendants
- K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019 · cites it directly18descendants
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) | K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek | 2017 | — |
| +1 | 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 | — |
| +3 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +1 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | 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 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K100976 | T2 XVBR 1.5 Spinal SystemSummary page 4…There are 4 Predicates. Primary Predicate 1- T2 ALTITUDE™ Expandable Corpectomy System (K100976, S.E. 10/21/2010) Predicate 2- Aesculap HydroLift VBR (K083186, S.E. 03/04/… | 2010 |
| * | K083186 | Aesculap Hydrolift VBR SystemSummary page 4…dicate 1- T2 ALTITUDE™ Expandable Corpectomy System (K100976, S.E. 10/21/2010) Predicate 2- Aesculap HydroLift VBR (K083186, S.E. 03/04/2010) Predicate Devices Predicate 3- T2 XVBRTM Spinal System (K… | 2010 |
| * | K071033 | T2 XVBR Spinal SystemSummary page 4…dicate 2- Aesculap HydroLift VBR (K083186, S.E. 03/04/2010) Predicate Devices Predicate 3- T2 XVBRTM Spinal System (K071033, S.E. 08/14/2007) Predicate 4- VERTE-STACK Spinal System® (K052931, S.E.… | 2007 |
| * | K052931 | Modification to Verte-Stack Spinal SystemSummary page 4…Predicate 3- T2 XVBRTM Spinal System (K071033, S.E. 08/14/2007) Predicate 4- VERTE-STACK Spinal System® (K052931, S.E. 11/16/2005) The predicates have not been subject to a design related… | 2005 |
What descends from it? (47)
See all 474 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | 2018 | 28 |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | 2019 | 27 |
| K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | 2019 | 18 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
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 16 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K181328 (Medtronic Sofamor Danek USA, Inc., 2018) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K100976.
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. 2017, 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 T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system 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 STRATOSPHERE™ Expandable Centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for…
Read the full statement (148 words)
The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system 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 STRATOSPHERE™ Expandable Centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracolumbar spine.
T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allograft, as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173125: T2 STRATOSPHERE™ Expandable Corpectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173125
Report an extraction error
Are you the manufacturer?
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