510(k) · Cleared
ClearedFidji-Vertebral Body Replacement Type 1, 2, 3 and 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Next America Corporation · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 29, 2004 as substantially equivalent to K011037 (Synthes (Usa), 2002) and 2 other predicates after a 96-day review. Its family tree reaches back 5 generations to 2001. 1 of the 857 devices in its family, counting itself, has a Class I recall. 838 later devices descend from it.
- Decided
- Dec 29, 2004
- Review
- 96 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K003155 (2001). 18 ancestors in all, the oldest K841189 (1984). 838 later devices descend from it, 3 citing it directly. 1 of the 857 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 4 generations backK012254 VBROsteotech, Inc. · 2001
- 3 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 2 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 1 generation backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- This deviceK042714 Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation · 2004
- Descendant · cites it directly · 834 of its ownK051246 Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005
- Descendant · 2 generations on · 754 of its ownK060350 Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006
- Descendant · 2 generations on · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 4 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
Showing 5 of 838 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 838 · See all- K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005 · cites it directly834descendants
- K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006 · 2 generations on754descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · 2 generations on753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 3 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 4 generations on696descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −4 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −3 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −2 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −1 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| 0 (this device) | K042714 | Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 | Spine Next America Corporation | 2004 | — |
| +1 | K051246 | Construx Mini Peek VBR System | Blackstone Medical, Inc. | 2005 | — |
| +2 | K060350 | Construx PL/TL Peek Partial VBR System | Blackstone Medical, Inc. | 2006 | — |
| +2 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +4 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 16 | 0 |
| 2015 | 23 | 0 |
| 2016 | 44 | 0 |
| 2017 | 58 | 0 |
| 2018 | 59 | 0 |
| 2019 | 68 | 0 |
| 2020 | 86 | 0 |
| 2021 | 71 | 1 |
| 2022 | 74 | 0 |
| 2023 | 85 | 0 |
| 2024 | 92 | 0 |
| 2025 | 78 | 0 |
| 2026 | 66 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K011037 | Vertebral Spacer | 2002 |
| * | K042268 | Ebi Cas Spine Spacer System Cleared while this submission was under review Summary page 1…uct Code: MQP Predicate Device: FIDJI types 1,2,3, and 4 are substantially equivalent to the Synthes Vertebral Spacer (KOI 1037), EBI CAS Spine Spacer (K042268), and Medtronic Sofamor Danek Vertestack (K031780). Device Description: The FIDJJ Vertebral Body Replacement Types 1, 2, 3, and… | 2004 |
| * | K031780 | Verte-Stack Spinal SystemSummary page 1…FIDJI types 1,2,3, and 4 are substantially equivalent to the Synthes Vertebral Spacer (KOI 1037), EBI CAS Spine Spacer (K042268), and Medtronic Sofamor Danek Vertestack (K031780). Device Description: The FIDJJ Vertebral Body Replacement Types 1, 2, 3, and 4 devices are hollow blocks that are machined from… | 2003 |
What descends from it? (838)
See all 8383 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K051246 (Blackstone Medical, Inc., 2005) has gone furthest, with 834 descendants of its own.
- 10 other devices also cite its predicate K011037.
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?
FIDJI types 1, 2, 3, and 4 are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042714: Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042714
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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