510(k) · Cleared
ClearedCOLOSSEUM Mesh
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 May 8, 2019 as substantially equivalent to K162315 (Globus Medical, Inc., 2017) and 3 other predicates after a 99-day review. Its family tree reaches back 15 generations to 1984.
- Decided
- May 8, 2019
- Review
- 99 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K841189 (1984). 63 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK152568 C-VBRCardinal Spine, LLC · 2016
- 2 generations backK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- 1 generation backK173982 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2018
- This deviceK190147 COLOSSEUM MeshGlobus Medical, Inc. · 2019
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 9 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 8 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 7 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 6 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 5 generations backK121176 STGCCardinal Spine, LLC · 2012
- 4 generations backK142030 STGC-LordoticCardinal Spine, LLC · 2015
- 3 generations backK152568 C-VBRCardinal Spine, LLC · 2016
- 2 generations backK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- 1 generation backK173982 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2018
- This deviceK190147 COLOSSEUM MeshGlobus Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −9 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −8 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −7 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −6 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −5 | K121176 | STGC | Cardinal Spine, LLC | 2012 | — |
| −4 | K142030 | STGC-Lordotic | Cardinal Spine, LLC | 2015 | — |
| −3 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| −2 | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| −1 | K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2018 | — |
| 0 (this device) | K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | 2019 | — |
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 |
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 |
|---|---|---|---|
| * | K162315 | FORTIFY Corpectomy SpacersSummary page 4…l Fixation Orthosis Product Code(s): MQP, PLR Regulatory Class II, Panel Code 87 Primary Predicate: FORTIFY® Corpectomy Spacers (K162315) Additional Predicates: FORTIFY® Corpectomy Spacers (K112756, K173982) Synthes SynMesh (K041389) Pu… | 2017 |
| * | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy SpacersSummary page 4…Regulatory Class II, Panel Code 87 Primary Predicate: FORTIFY® Corpectomy Spacers (K162315) Additional Predicates: FORTIFY® Corpectomy Spacers (K112756, K173982) Synthes SynMesh (K041389) Purpose: The purpose of this submission is to request clearance for COLO… | 2011 |
| * | K173982 | FORTIFY Corpectomy SpacersSummary page 4…Regulatory Class II, Panel Code 87 Primary Predicate: FORTIFY® Corpectomy Spacers (K162315) Additional Predicates: FORTIFY® Corpectomy Spacers (K112756, K173982) Synthes SynMesh (K041389) Purpose: The purpose of this submission is to request clearance for COLOSSEUM™ Me… | 2018 |
| * | K041389 | Synthes Contoured Synmesh SpacerSummary page 4…mary Predicate: FORTIFY® Corpectomy Spacers (K162315) Additional Predicates: FORTIFY® Corpectomy Spacers (K112756, K173982) Synthes SynMesh (K041389) Purpose: The purpose of this submission is to request clearance for COLOSSEUM™ Mesh. Device Description: COLOSSEUM™ Mesh are d… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 63 ancestors have a recall of any class.
- 6 other devices also cite its predicate K162315.
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. 2019, 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?
When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™ Mesh devices 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…
Read the full statement (251 words)
When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™ Mesh devices 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 as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh 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 vertebral body replacement device 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 as stated in the FDA summary.
https://510kreport.com/device/K190147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190147: COLOSSEUM Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190147
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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