510(k) Report

510(k) · Cleared

Cleared

Reliance VBS System

K063637510(k) TraditionalCleared Sep 27, 2007294-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

Reliance Medical Systems, LLC · MQP Spinal Vertebral Body Replacement Device

Cleared on Sep 27, 2007 as substantially equivalent to K043206 (Pioneer Surgical Technology, 2005) and 17 other predicates after a 294-day review. Its family tree reaches back 8 generations to 1984. 1 later device descends from it.

Decided
Sep 27, 2007
Review
294 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
18

Its longest line of descent runs back 8 generations to K841189 (1984). 50 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 3 other ancestors2004: 14 other ancestors2003: 9 other ancestors2002: 6 other ancestors2000: 2 other ancestors2001: 8 other ancestors2008: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K051454 · Aleutian Spacer System · K2m, LLC · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors2 generations back: 11 other ancestors3 generations back: 10 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 1 descendant K051454 · Aleutian Spacer System · K2m, LLC · 2005K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 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 · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 2 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 1 generation backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. This deviceK063637 Reliance VBS SystemReliance Medical Systems, LLC · 2007
  10. Descendant · cites it directly · 0 of its ownK081383 Reliance VBS SystemReliance Medical Systems, LLC · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K081383Reliance VBS SystemReliance Medical Systems, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−7K990148Stackable Cage SystemDepuy Motech Acromed1999—
−6K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−5K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−4K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−3K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−2K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−1K051454Aleutian Spacer SystemK2m, LLC2005—
0 (this device)K063637Reliance VBS SystemReliance Medical Systems, LLC2007—
+1K081383Reliance VBS SystemReliance Medical Systems, LLC2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200180
200260
200390
2004140
200530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K063637, 1984–2008Source: 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? (18)

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
*K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)
Summary page 1
…ode: MQP Substantial Equivalence The Reliance VBS is substantially equivalent to the legally marketed Pioneer Surgical Vertebral Spacer (K043206), the Alphatec NOVEL VBR (K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), t…
Pioneer Surgical Technology2005—
*K042201Novel VBR Spinal System
Summary page 1
…MQP Substantial Equivalence The Reliance VBS is substantially equivalent to the legally marketed Pioneer Surgical Vertebral Spacer (K043206), the Alphatec NOVEL VBR (K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-…
Alphatec/Nexmed2004—
*K050449Quantum Vertebral Body Replacement
Summary page 1
…s substantially equivalent to the legally marketed Pioneer Surgical Vertebral Spacer (K043206), the Alphatec NOVEL VBR (K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422,…
Quantum Orthopedics, Inc.2005—
*K051454Aleutian Spacer SystemK2m, LLC2005—
*K041556Modification to Verte-Stack Spinal System
Summary page 1
…lphatec NOVEL VBR (K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO0…
Medtronic Sofamor Danek2004—
*K041452Modification to Verte-Stack Spinal System
Summary page 1
…OVEL VBR (K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K02…
Medtronic Sofamor Danek2004—
*K040536Modification to Verte-Stack Spinal System
Summary page 1
…(K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K02…
Medtronic Sofamor Danek2004—
*K040422Modification to Verte-Stack
Summary page 1
…, the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). Th…
Medtronic Sofamor Danek2004—
*K040167Verte-Stack Spinal System
Summary page 1
…ntum Vertebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Relianc…
Medtronic Sofamor Danek2004—
*K031780Verte-Stack Spinal System
Summary page 1
…ebral Body Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is…
Medtronic Sofamor Danek2003—
*K030736Verte-Stack Spinal System, Extra Small Sizes
Summary page 1
…y Replacement (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is equivalen…
Medtronic Sofamor Danek2003—
*K030735Modified Verte-Stack Spinal System
Summary page 1
…ment (K050449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is equivalent to thes…
Medtronic Sofamor Danek2003—
*K030601Verte-Stack Spinal System
Summary page 1
…0449), the K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is equivalent to these commerc…
Medtronic Sofamor Danek2003—
*K023570Modification to Verte-Stack Spinal System
Summary page 1
…e K2M Aleutian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is equivalent to these commercially ava…
Medtronic Sofamor Danek2002—
*K021791Verte-Stack Spinal System
Summary page 1
…utian Spacer System (KO51454), the Medtronic Sofamor Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is equivalent to these commercially available de…
Medtronic Sofamor Danek2002—
*K001037Modification to Ebi Spinelink SystemEbi, L.P.2000—
*K020152Synthes Vertebral Spacer TI
Summary page 1
…Flanek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is equivalent to these commercially available devices in terms of material, intended use, levels of a…
Synthes (Usa)2002—
*K024364Synthes Vertebral Spacer TI (Curved and Narrow)
Summary page 1
…rte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030735, K030601, K023570, K021791), and the Synthes Vertebral Spacer (KO01037, K020152, K024364). The Reliance VBS is equivalent to these commercially available devices in terms of material, intended use, levels of attachment…
Synthes (Usa)2003—

Also cleared against K043206: 11 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081383Reliance VBS SystemReliance Medical Systems, LLC20080

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 23 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
  • 3 of the 50 ancestors have a recall of any class.
  • Of its descendants, K081383 (Reliance Medical Systems, LLC, 2008) has gone furthest, with 0 descendants of its own.
  • 11 other devices also cite its predicate K043206.

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. 2007, this device’s year, is highlighted.

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 Reliance VBS System is intended for use in the thoracolumbar spine (Ti-LS) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K043206

11 other devices cite the same predicate.

  • K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
  • K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2015
  • K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 20141 recall
  • K133623C-PLUSPioneer Surgical Technology, Inc. · 2014
  • K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
  • K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC · 2010

More from Reliance Medical Systems, LLC

24 FDA decisions under this applicant name. See the company

  • K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2022
  • K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
  • K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2019
  • K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC · 2018
  • K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017

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/K063637 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063637: Reliance VBS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063637

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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