510(k) · Cleared
ClearedFortify (TM) and Fortify (TM)-R Corpectomy Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 7, 2011 as substantially equivalent to K050850 (Globus Medical, Inc., 2005) and 4 other predicates after a 16-day review. Its family tree reaches back 9 generations to 2001. 268 later devices descend from it.
- Decided
- Oct 7, 2011
- Review
- 16 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K003155 (2001). 30 ancestors in all, the oldest K841189 (1984). 268 later devices descend from it, 7 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 deviceK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 214 of its ownK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
- Descendant · cites it directly · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
- Descendant · 2 generations on · 109 of its ownK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
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 deviceK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
Showing 5 of 268 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 268 · See all- K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012 · cites it directly214descendants
- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · cites it directly210descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
- K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 2 generations on117descendants
- K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017 · 2 generations on109descendants
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) | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy Spacers | Globus Medical, Inc. | 2011 | — |
| +1 | K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R) | Globus Medical, Inc. | 2012 | — |
| +1 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +1 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
| +2 | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016 | — |
| +2 | K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | 2017 | — |
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 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K050850 | Xpand Corpectomy SpacerSummary page 1…Product Code MQP. Regulatory Class 11,Panel Code 87. Predicate(s): XPand® and XPand® Radiolucent Corpectomy Spacers (K050850 and K060665), Stryker Spine VLIFT10 Vertebral Body Replacement System (K060506) and Synthes SynMesh®… | 2005 |
| * | K060665 | Xpand Radiolucent Corpectomy SpacerSummary page 1…Product Code MQP. Regulatory Class 11,Panel Code 87. Predicate(s): XPand® and XPand® Radiolucent Corpectomy Spacers (K050850 and K060665), Stryker Spine VLIFT10 Vertebral Body Replacement System (K060506) and Synthes SynMesh® Spacer… | 2006 |
| * | K060506 | Stryker Spine Vlift Vertebral Body Replacement SystemSummary page 1…s): XPand® and XPand® Radiolucent Corpectomy Spacers (K050850 and K060665), Stryker Spine VLIFT10 Vertebral Body Replacement System (K060506) and Synthes SynMesh® Spacers (K003275 & K041389) Purpose: The purpose of this submission is to request clearanc… | 2006 |
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 1…(K050850 and K060665), Stryker Spine VLIFT10 Vertebral Body Replacement System (K060506) and Synthes SynMesh® Spacers (K003275 & K041389) Purpose: The purpose of this submission is to request clearance for the FORTIFYTM and FORTIFYTM-R Corpectomy Spacers.… | 2001 |
| * | K041389 | Synthes Contoured Synmesh SpacerSummary page 1…(K050850 and K060665), Stryker Spine VLIFT10 Vertebral Body Replacement System (K060506) and Synthes SynMesh® Spacers (K003275 & K041389) Purpose: The purpose of this submission is to request clearance for the FORTIFYTM and FORTIFYTM-R Corpectomy Spacers. Device De… | 2004 |
What descends from it? (268)
See all 2687 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R) | 2012 | 214 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K162315 | FORTIFY Corpectomy Spacers | 2017 | 55 |
| K173982 | FORTIFY Corpectomy Spacers | 2018 | 8 |
| K190147 | COLOSSEUM Mesh | 2019 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K121107 (Globus Medical, Inc., 2012) has gone furthest, with 214 descendants of its own.
- 4 other devices also cite its predicate K050850.
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. 2011, 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?
FORTIFYTM and FORTFYTM-R Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L-5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112756: Fortify (TM) and Fortify (TM)-R Corpectomy Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112756
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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