510(k) Report

510(k) · Cleared

Cleared

Fidji-Vertebral Body Replacement Type 5

K042713510(k) TraditionalCleared Dec 29, 200490-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spine Next America Corporation · MQP Spinal Vertebral Body Replacement Device

Cleared on Dec 29, 2004 as substantially equivalent to K011037 (Synthes (Usa), 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 2001.

Decided
Dec 29, 2004
Review
90 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K003155 (2001). 10 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1984: 1 other ancestorK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor3 generations back: 4 other ancestors K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−50
  1. Root · 5 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 4 generations backK012254 VBROsteotech, Inc. · 2001
  3. 3 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 2 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 1 generation backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. This deviceK042713 Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−4K012254VBROsteotech, Inc.2001—
−3K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−2K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−1K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
0 (this device)K042713Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
200010
200120
200210
FIG. 1 — Lineage of K042713, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K011037Vertebral Spacer
Summary page 1
…Class II Proprietary Name: Spine Next FIDJI Vertebral Body Replacement Type 5 PREDICATE DEVICE Vertebral Spacer manufactured by Synthes [reference 5 10(k) K01 1037, cleared July 1, 2002] Vertestack manufactured by Medtronic Sofamor Danek [reference 5 10(k) K03 1780, cleared July 30, 2003] T…
Synthes (Usa)2002—
*K031780Verte-Stack Spinal System
Summary page 1
…EVICE Vertebral Spacer manufactured by Synthes [reference 5 10(k) K01 1037, cleared July 1, 2002] Vertestack manufactured by Medtronic Sofamor Danek [reference 5 10(k) K03 1780, cleared July 30, 2003] This summary of 5lO (k) safety and effectiveness information is being submitted in accordance with the r…
Medtronic Sofamor Danek2003—

Also cleared against K011037: 10 other devices →

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 3 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • None of the 10 ancestors has a recall.
  • 10 other devices also cite its predicate K011037.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-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. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.

Indications for use as stated in the FDA summary.

Also cleared against K011037

10 other devices cite the same predicate.

  • K081383Reliance VBS SystemReliance Medical Systems, LLC · 2008
  • K072981Synthes Zero-PSynthes Spine Co.Lp · 20082 recalls
  • K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  • K062083Synfix -LRSynthes Spine Co.Lp · 2007
  • K062933Synthes Oracle SpacerSynthes Spine Co.Lp · 2007
  • K053508Synfix-LRSynthes Spine Co.Lp · 20061 recall

More from Spine Next America Corporation

2 FDA decisions under this applicant name. See the company

  • K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation · 2004

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K042713 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042713: Fidji-Vertebral Body Replacement Type 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042713

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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