510(k) · Cleared
ClearedFORTIFY 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 Nov 9, 2017 as substantially equivalent to K151651 (Nu Vasive, Incorporated, 2015) and 2 other predicates after a 448-day review. Its family tree reaches back 13 generations to 1984. 55 later devices descend from it.
- Decided
- Nov 9, 2017
- Review
- 448 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K841189 (1984). 61 ancestors in all. 55 later devices descend from it, 7 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK121176 STGCCardinal Spine, LLC · 2012
- 2 generations backK142030 STGC-LordoticCardinal Spine, LLC · 2015
- 1 generation backK152568 C-VBRCardinal Spine, LLC · 2016
- This deviceK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 2 generations on · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 21 of its ownK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 4 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · 5 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 7 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 6 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 5 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 4 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 3 generations backK121176 STGCCardinal Spine, LLC · 2012
- 2 generations backK142030 STGC-LordoticCardinal Spine, LLC · 2015
- 1 generation backK152568 C-VBRCardinal Spine, LLC · 2016
- This deviceK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · 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 · 2 generations on27descendants
- K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 3 generations on21descendants
- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · 4 generations on20descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −7 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −6 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −5 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −4 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −3 | K121176 | STGC | Cardinal Spine, LLC | 2012 | — |
| −2 | K142030 | STGC-Lordotic | Cardinal Spine, LLC | 2015 | — |
| −1 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| 0 (this device) | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| +1 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +2 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +4 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +5 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 12 | 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? (3)
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 |
|---|---|---|---|
| * | K151651 | NuVasive X-CORE Mini Cervical Expandable VBR SystemSummary page 4…vertebral Fixation Orthosis Product Code: MQP, PLR Regulatory Class: II, Panel Code: 87 Primary Predicate: NuVasive X-Core Mini (K151651) Additional FORTIFY® Corpectomy Spacers (K112756) Predicates: Cardinal Spine C-VBR (K152568) Purpose: The purp… | 2015 |
| * | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy SpacersSummary page 4…e: MQP, PLR Regulatory Class: II, Panel Code: 87 Primary Predicate: NuVasive X-Core Mini (K151651) Additional FORTIFY® Corpectomy Spacers (K112756) Predicates: Cardinal Spine C-VBR (K152568) Purpose: The purpose of this submission is to request additional indications… | 2011 |
| * | K152568 | C-VBRSummary page 4…I, Panel Code: 87 Primary Predicate: NuVasive X-Core Mini (K151651) Additional FORTIFY® Corpectomy Spacers (K112756) Predicates: Cardinal Spine C-VBR (K152568) Purpose: The purpose of this submission is to request additional indications for FORTIFY® Corpectomy Spacers (titanium) for use… | 2016 |
What descends from it? (55)
See all 557 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 |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | 2018 | 9 |
| K173982 | FORTIFY Corpectomy Spacers | 2018 | 8 |
| K180673 | Normandy VBR System | 2018 | 7 |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | 2019 | 5 |
| K183071 | VLIFT-s Vertebral Body Replacement System | 2019 | 4 |
| 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 33 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 61 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.
- 8 other devices also cite its predicate K151651.
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?
FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated versions. When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased…
Read the full statement (283 words)
FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated versions.
When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
When used in the thoracolumbar spine (T1-L5), FORTIFY® and FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162315: FORTIFY 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/K162315
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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