510(k) · Cleared
ClearedStryker Spine Vlift Vertebral Body Replacement System
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 May 25, 2006 as substantially equivalent to K050624 (Stryker Spine, 2005) and 3 other predicates after an 87-day review. Its family tree reaches back 8 generations to 2001. 270 later devices descend from it.
- Decided
- May 25, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K003155 (2001). 21 ancestors in all, the oldest K841189 (1984). 270 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations backK012254 VBROsteotech, Inc. · 2001
- 6 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 4 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 3 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 2 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 1 generation backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- This deviceK060506 Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006
- Descendant · cites it directly · 268 of its ownK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
- Descendant · 2 generations on · 214 of its ownK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
- Descendant · 2 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · 2 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- Descendant · 3 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
Showing 5 of 270 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 270 · See all- K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011 · cites it directly268descendants
- K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012 · 2 generations on214descendants
- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 2 generations on210descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 2 generations on149descendants
- K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 3 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −7 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −6 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −4 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −3 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −2 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| 0 (this device) | K060506 | Stryker Spine Vlift Vertebral Body Replacement System | Stryker Spine | 2006 | — |
| +1 | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy Spacers | Globus Medical, Inc. | 2011 | — |
| +2 | K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R) | Globus Medical, Inc. | 2012 | — |
| +2 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +2 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
| +3 | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 8 | 0 |
| 2018 | 9 | 0 |
| 2019 | 14 | 0 |
| 2020 | 19 | 0 |
| 2021 | 18 | 0 |
| 2022 | 26 | 0 |
| 2023 | 40 | 0 |
| 2024 | 49 | 0 |
| 2025 | 45 | 0 |
| 2026 | 37 | 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 |
|---|---|---|---|
| * | K050624 | Stryker Spine Avs PL Peek SpacerSummary page 1…al Intervertebral Body Fixation Orthosis and Number 21 CFR 888.3060 Product Code MQP Predicate Devices 1) Stryker Spine AVSIM PL Peek Spacer (K050624), Product Code MQP, Class II TM… | 2005 |
| * | K003836 | Synthes Synex Spacer SystemSummary page 1…TM M Spacer 2) Synthes Spine Synex T System (K003836), Product Code MQP, Class II 3) Surgical Dynamics Mesh Cage Syste… | 2001 |
| * | K003709 | Surgical Dynamics Mesh Cage SystemSummary page 1…e Synex T System (K003836), Product Code MQP, Class II 3) Surgical Dynamics Mesh Cage System (K003709), Product Code MQP, Class II 4) DePuy Harms Mesh Cage (K003043),… | 2001 |
| * | K003043 | Surgical Titanium Mesh SystemSummary page 1…3) Surgical Dynamics Mesh Cage System (K003709), Product Code MQP, Class II 4) DePuy Harms Mesh Cage (K003043), Product Code MQP, Class II Device Description Stryker Spine VLIFTIM is a vertebral body… | 2001 |
What descends from it? (270)
See all 2703 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 5 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K112756 (Globus Medical, Inc., 2011) has gone furthest, with 268 descendants of its own.
- 7 other devices also cite its predicate K050624.
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.
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?
Stryker Spine VLIFT TM is a vertebral body replacement system 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, the VLIFTTM system is intended to be…
Read the full statement (117 words)
Stryker Spine VLIFT TM is a vertebral body replacement system 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, the VLIFTTM system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT TM include, but are not limited to Stryker Spine plate or rod systems (Xia®Spinal System, Spiral Radius 90D, and Trio). The use of bone graft with VLIFTTM is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060506 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060506: Stryker Spine Vlift Vertebral Body Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060506
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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