510(k) Report

510(k) · Cleared

Cleared

Spinal Usa VBR System

K061752510(k) TraditionalCleared Aug 15, 200655-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

Spinal USA · MQP Spinal Vertebral Body Replacement Device

Cleared on Aug 15, 2006 as substantially equivalent to K042201 (Alphatec/Nexmed, 2004) and 6 other predicates after a 55-day review. Its family tree reaches back 7 generations to 1984.

Decided
Aug 15, 2006
Review
55 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
7

Its longest line of descent runs back 7 generations to K841189 (1984). 33 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2004: 8 other ancestors2002: 4 other ancestors2001: 8 other ancestors2000: 1 other ancestor2003: 3 other ancestorsK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K050348 · CO Vertebral Body Replacement · Scient'X · 2005198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 8 other ancestors4 generations back: 5 other ancestors K050348 · CO Vertebral Body Replacement · Scient'X · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−50
  1. Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 2 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 1 generation backK050348 CO Vertebral Body ReplacementScient'X · 2005
  8. This deviceK061752 Spinal Usa VBR SystemSpinal USA · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−6K990148Stackable Cage SystemDepuy Motech Acromed1999—
−5K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−4K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−3K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−2K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−1K050348CO Vertebral Body ReplacementScient'X2005—
0 (this device)K061752Spinal Usa VBR SystemSpinal USA2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200180
200240
200330
200480
200520
FIG. 1 — Lineage of K061752, 1984–2006Source: 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? (7)

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
*K042201Novel VBR Spinal System
Summary page 1
…trates that the Intervertebral Body Fusion device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stac…
Alphatec/Nexmed2004—
*K052384Lanx VBR System
Summary page 1
…ral Body Fusion device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quant…
Lanx, LLC2005—
*K990148Stackable Cage System
Summary page 1
…l VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Signus Medical (K031757), CO VBR Scient'X(K050348), Ellys and Aurys VBR…
Depuy Motech Acromed1999—
*K050449Quantum Vertebral Body Replacement
Summary page 1
…stem (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Signus Medical (K031757), CO VBR Scient'X(K050348), Ellys and Aurys VBR Tetris…
Quantum Orthopedics, Inc.2005—
*K031757Peek Tetris Spinal Implant
Summary page 1
…Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Signus Medical (K031757), CO VBR Scient'X(K050348), Ellys and Aurys VBR Tetris…
Signus Medical, LLC2003—
*K050348CO Vertebral Body Replacement
Summary page 1
…Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Signus Medical (K031757), CO VBR Scient'X(K050348), Ellys and Aurys VBR Tetris Scient'X (K0…
Scient'X2005—
*K033109Ellys and Aurys Vertebral Body Replacements
Summary page 1
…Medical (K031757), CO VBR Scient'X(K050348), Ellys and Aurys VBR Tetris Scient'X (K033109). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Scient'X2004—

Also cleared against K042201: 4 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 22 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
  • 2 of the 33 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K042201.

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 Spinal USA VBR System 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 Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column The Spinal USA VBR System is intended to be used with…

Read the full statement (118 words)

The Spinal USA VBR System 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 Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column

The Spinal USA VBR System 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). In addition, the Spinal USA VBR System is intended for use with bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K042201

4 other devices cite the same predicate.

  • K081383Reliance VBS SystemReliance Medical Systems, LLC · 2008
  • K063637Reliance VBS SystemReliance Medical Systems, LLC · 2007
  • K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  • K052170Seaspine VBR SystemSeaspine, Inc. · 2005

More from Spinal USA

23 FDA decisions under this applicant name. See the company

  • K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
  • K130863Facet Screw SystemSpinal USA · 2013
  • K131343Reform Pedicle Screw SystemSpinal USA · 2013
  • K130279Reform Pedicle Screw SystemSpinal USA · 2013
  • K130445Vault Alif SystemSpinal USA · 2013

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/K061752 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061752: Spinal Usa VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061752

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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