510(k) · Cleared
ClearedVlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MQP Spinal Vertebral Body Replacement Device
Cleared on Sep 25, 2009 as substantially equivalent to K060506 (Stryker Spine, 2006) and 4 other predicates after an 87-day review. Its family tree reaches back 9 generations to 2001. 5 later devices descend from it.
- Decided
- Sep 25, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K003155 (2001). 27 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations between
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK060506 Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006
- This deviceK091946 Vlift-S Vertebral Body Replacement System, Models 488812XX…Stryker Spine · 2009
- Descendant · cites it directly · 4 of its ownK183071 VLIFT-s Vertebral Body Replacement SystemStryker Spine · 2019
- Descendant · 2 generations on · 1 of its ownK241468 Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
- Descendant · 3 generations on · 0 of its ownK261810 Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
- Descendant · 3 generations on · 0 of its ownK262061 Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium®…Stryker Spine · 2026
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 backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 4 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK060506 Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006
- This deviceK091946 Vlift-S Vertebral Body Replacement System, Models 488812XX…Stryker Spine · 2009
Most influential descendants
Showing 5 of 5 · See all- K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine · 2019 · cites it directly4descendants
- K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024 · 2 generations on1descendant
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · 2 generations on1descendant
- K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026 · 3 generations on0descendants
- K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine · 2026 · 3 generations on0descendants
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 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −4 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −3 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K060506 | Stryker Spine Vlift Vertebral Body Replacement System | Stryker Spine | 2006 | — |
| 0 (this device) | K091946 | Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX… | Stryker Spine | 2009 | — |
| +1 | K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | 2019 | — |
| +2 | K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024 | — |
| +2 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
| +3 | K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026 | — |
| +3 | K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved… | Stryker Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K060506 | Stryker Spine Vlift Vertebral Body Replacement SystemSummary page 1…s, 21 CFR 888.3060 and Number Product Code MQP Predicate Devices Stryker Spine VLIFT® Vertebral Body Replacement System [K060506], DePuy X-MESHTM Expandable Cage System [K080568], Synthes Spine Synex T M II Spacer [K061891],… | 2006 |
| * | K080568 | X-Mesh Expandable Cage SystemSummary page 1…MQP Predicate Devices Stryker Spine VLIFT® Vertebral Body Replacement System [K060506], DePuy X-MESHTM Expandable Cage System [K080568], Synthes Spine Synex T M II Spacer [K061891], Surgical Dynamics TM Mesh Cage… | 2008 |
| * | K061891 | Synex IISummary page 1…dy Replacement System [K060506], DePuy X-MESHTM Expandable Cage System [K080568], Synthes Spine Synex T M II Spacer [K061891], Surgical Dynamics TM Mesh Cage System, [K003709] and DePuy AcroMed Surgical… | 2006 |
| * | K003709 | Surgical Dynamics Mesh Cage SystemSummary page 1…xpandable Cage System [K080568], Synthes Spine Synex T M II Spacer [K061891], Surgical Dynamics TM Mesh Cage System, [K003709] and DePuy AcroMed Surgical Titanium MeshTM [K003043] Product Code MQP, Class… | 2001 |
| * | K003043 | Surgical Titanium Mesh SystemSummary page 1…T M II Spacer [K061891], Surgical Dynamics TM Mesh Cage System, [K003709] and DePuy AcroMed Surgical Titanium MeshTM [K003043] Product Code MQP, Class II Device Description The VLIFT®-s Distractible In-s… | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183071 | VLIFT-s Vertebral Body Replacement System | 2019 | 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 8 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K183071 (Stryker Spine, 2019) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K060506.
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 VLIFT6-s system is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to tumor or trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, VLIFT0-s system is intended to be used with supplemental internal…
Read the full statement (124 words)
The VLIFT6-s system is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to tumor or trauma (i.e., fracture).
For both corpectomy and vertebrectomy procedures, VLIFT0-s system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT-s system include, but are not limited to, Stryker Spine plate or rod systems (e.g., Xia® Spinal System, Radius ® Spinal System, Mantis ® Percutaneous Spinal System, Thor® Plating System, Trio®+Spinal System). The use of bone graft with VLIFIT--s system is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091946: Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091946
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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