510(k) · Cleared
ClearedFortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)
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 Jul 3, 2012 as substantially equivalent to K112756 (Globus Medical, Inc., 2011) and 1 other predicate after an 82-day review. Its family tree reaches back 10 generations to 2001. 214 later devices descend from it.
- Decided
- Jul 3, 2012
- Review
- 82 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K003155 (2001). 32 ancestors in all, the oldest K841189 (1984). 214 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 6 generations between
- 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 2 generations backK060506 Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006
- 1 generation backK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
- This deviceK121107 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
- Descendant · 2 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations backK012254 VBROsteotech, Inc. · 2001
- 8 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 5 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 4 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 2 generations backK060506 Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006
- 1 generation backK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
- This deviceK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
Showing 5 of 214 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 214 · See all- 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
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 2 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −9 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −8 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −5 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −4 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 18 | 0 |
| 2022 | 23 | 0 |
| 2023 | 34 | 0 |
| 2024 | 40 | 0 |
| 2025 | 38 | 0 |
| 2026 | 26 | 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? (2)
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 |
|---|---|---|---|
| * | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy SpacersSummary page 1…orthosis devices Product Code MQP. Regulatory Class 11,Panel Code 87. Predicate(s): FORTIFY TM Corpectomy Spacers (K1 12756) Ulrich Add PIUSTM (K090841) Purpose: The purpose of this submission is to request clearance for the FORTIFY In… | 2011 |
| * | K090841 | AddplusSummary page 1…Product Code MQP. Regulatory Class 11,Panel Code 87. Predicate(s): FORTIFY TM Corpectomy Spacers (K1 12756) Ulrich Add PIUSTM (K090841) Purpose: The purpose of this submission is to request clearance for the FORTIFY Integrated Corpectomy Spacers. Device Descript… | 2009 |
What descends from it? (214)
See all 2144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K162133 | VerteFIT Corpectomy Cage System | 2017 | 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 11 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 32 ancestors have a recall of any class.
- Of its descendants, K143578 (Globus Medical, Inc., 2016) has gone furthest, with 210 descendants of its own.
- 6 other devices also cite its predicate K112756.
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. 2012, 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 Integrated Corpectomy Spacers (FORTIFYTM I and FORTIFYTM l-R) are vertebral body replacement devices intended for use in thd thoracolumbar spine (T 1-5) 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…
Read the full statement (113 words)
FORTIFYTM Integrated Corpectomy Spacers (FORTIFYTM I and FORTIFYTM l-R) are vertebral body replacement devices intended for use in thd thoracolumbar spine (T 1-5) 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/K121107 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121107: Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121107
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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