510(k) Report

510(k) · Cleared

Cleared

Modification to Quantum Vertebral Body Replacement

K062004510(k) SpecialCleared Aug 15, 200629-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

Quantum Orthopedics, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Aug 15, 2006 after a 29-day review. The FDA summary names its predicate without a number. 64 later devices descend from it.

Decided
Aug 15, 2006
Review
29 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
0

64 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2008: 2 descendants cleared2011: 1 descendant cleared2014: 2 descendants cleared2013: 2 descendants cleared2019: 1 descendant cleared2015: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2018: 3 descendants cleared2021: 2 descendants cleared2020: 4 descendants cleared2024: 8 descendants cleared2023: 9 descendants cleared2025: 9 descendants cleared2026: 10 descendants cleared2022: 4 descendants cleared20052010201520202025
  1. This deviceK062004 Modification to Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2006
  2. Descendant · cites it directly · 60 of its ownK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  3. Descendant · 2 generations on · 55 of its ownK082270 Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
  4. Descendant · 3 generations on · 47 of its ownK132582 Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014 · Recalled
  5. Descendant · 4 generations on · 39 of its ownK171489 Acapella Cervical Spacer SystemChoicespine, LP · 2017
  6. Descendant · 5 generations on · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2007: 32008: 22011: 12013: 22014: 22015: 22016: 12017: 12018: 32019: 12020: 42021: 22022: 42023: 92024: 82025: 92026: 10
2007high 10 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 64 · See all
  • K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007 · cites it directly60descendants
  • K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008 · 2 generations on55descendants
  • K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014 · 3 generations on47descendants
  • K171489Acapella Cervical Spacer SystemChoicespine, LP · 2017 · 4 generations on39descendants
  • K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · 5 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062004Modification to Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2006—
+1K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated2007—
+2K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.2008—
+3K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.20141
+4K171489Acapella Cervical Spacer SystemChoicespine, LP2017—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200820
201110
201320
201420
201520
201610
201710
201830
201910
202040
202120
202240
202390
202480
202590
2026100
FIG. 1 — Lineage of K062004, 2006–2026Source: 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? (1)

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
*—Quantum Vertebral Body Replacement
Named without a submission number
—

What descends from it? (64)

See all 64

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760
K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072

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?

  • Of its descendants, K070218 (Vertiflex (Tm), Incorporated, 2007) has gone furthest, with 60 descendants of its own.

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?

The Quantum Vertebral Body Replacement is 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).

This device is intended to be used with supplemental spinal fixation systems that have been cleared 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 spacer can be packed with allograft or autograft.

Indications for use as stated in the FDA summary.

More from Quantum Orthopedics, Inc.

5 FDA decisions under this applicant name. See the company

  • K061576Modification to Quantum Vertebral Body Replacement SystemQuantum Orthopedics, Inc. · 2006
  • K052641Modification to: Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2006
  • K060491Quantum Anterior Cervical Plate SystemQuantum Orthopedics, Inc. · 2006
  • K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2005

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/K062004 · printed Nov 3, 2026

Cite this page

510(k) Report. “K062004: Modification to Quantum Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K062004

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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