510(k) Report

510(k) · Cleared

Cleared

Creaspine Supstance Vertebral Body Replacement System Line Extension

K081564510(k) SpecialCleared Jun 30, 200826-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

Creaspine · MQP Spinal Vertebral Body Replacement Device

Cleared on Jun 30, 2008 as substantially equivalent to K072537 (Creaspine Sas, 2007) and 2 other predicates after a 26-day review. Its family tree reaches back 9 generations to 1984.

Decided
Jun 30, 2008
Review
26 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K841189 (1984). 16 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 4 other ancestors2004: 2 other ancestors2000: 1 other ancestorK841189 · 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 · 2003K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K050058 · Theken Reveal VBR System · Theken Surgical,Llc · 2005K070381 · Theken VU Mesh VBR System · Theken Spine, LLC · 2007K072537 · Creaspine Supstance Vertebral Body Replacement System · Creaspine Sas · 20071980198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor K072537 · Creaspine Supstance Vertebral Body Replacement System · Creaspine Sas · 2007K070381 · Theken VU Mesh VBR System · Theken Spine, LLC · 2007K050058 · Theken Reveal VBR System · Theken Surgical,Llc · 2005K041888 · 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 · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 5 generations between
  3. 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
  4. 2 generations backK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  5. 1 generation backK072537 Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas · 2007
  6. This deviceK081564 Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine · 2008
Show all 9 generations
  1. Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
  8. 2 generations backK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  9. 1 generation backK072537 Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas · 2007
  10. This deviceK081564 Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−8K990148Stackable Cage SystemDepuy Motech Acromed1999—
−7K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−6K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−5K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−4K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−3K050058Theken Reveal VBR SystemTheken Surgical,Llc2005—
−2K070381Theken VU Mesh VBR SystemTheken Spine, LLC2007—
−1K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas2007—
0 (this device)K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200140
200420
FIG. 1 — Lineage of K081564, 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K072537Creaspine Supstance Vertebral Body Replacement System
Summary page 1
…Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System), Line Extension is substantially equivalent to the Creaspine SupStance VBR System subject of K072537 and the following legally marketed spinal vertebral body replacement devices: · Surgical Titanium MeshTm System (DePuy-Ac…
Creaspine Sas2007—
*K003043Surgical Titanium Mesh System
Summary page 1
…System subject of K072537 and the following legally marketed spinal vertebral body replacement devices: · Surgical Titanium MeshTm System (DePuy-AcromedTM, Inc., K003043) * Surgical Dynamics Mesh Cage System (United States Surgical, K003709) Device Description The proposed Creaspine SupStan…
Depuyacromed2001—
*K003709Surgical Dynamics Mesh Cage System
Summary page 1
…body replacement devices: · Surgical Titanium MeshTm System (DePuy-AcromedTM, Inc., K003043) * Surgical Dynamics Mesh Cage System (United States Surgical, K003709) Device Description The proposed Creaspine SupStance VBR System, Line Extension, is a modification of the original Creaspine Sup…
United States Surgical, A Division of Tyco Healthc2001—

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 24 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
  • 3 of the 16 ancestors have a recall of any class.

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. 2008, 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 Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (Ti- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

Indications for use as stated in the FDA summary.

More from Creaspine

2 FDA decisions under this applicant name. See the company

  • K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine · 2008

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/K081564 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081564: Creaspine Supstance Vertebral Body Replacement System Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081564

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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