510(k) Report

510(k) · Cleared

Cleared

Creaspine Supstance Small Vertebral Body Replacement System

K080860510(k) TraditionalCleared May 29, 200863-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 May 29, 2008 as substantially equivalent to K003043 (Depuyacromed, 2001) and 2 other predicates after a 63-day review. Its family tree reaches back 8 generations to 2001.

Decided
May 29, 2008
Review
63 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 8 generations to K003155 (2001). 29 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 5 other ancestors2004: 4 other ancestors2003: 6 other ancestors1999: 1 other ancestor1984: 1 other ancestor2002: 2 other ancestors1998: 1 other ancestor2000: 1 other ancestorK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K030736 · Verte-Stack Spinal System, Extra Small Sizes · Medtronic Sofamor Danek · 2003K041452 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K043566 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2005K052670 · Staxx XD System · Spine Wave, Inc. · 20061980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 5 other ancestors4 generations back: 5 other ancestors5 generations back: 2 other ancestors K052670 · Staxx XD System · Spine Wave, Inc. · 2006K043566 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2005K041452 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030736 · Verte-Stack Spinal System, Extra Small Sizes · 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 · 8 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations backK012254 VBROsteotech, Inc. · 2001
  3. 6 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 5 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 4 generations backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
  6. 3 generations backK041452 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 2 generations backK043566 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
  8. 1 generation backK052670 Staxx XD SystemSpine Wave, Inc. · 2006
  9. This deviceK080860 Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−7K012254VBROsteotech, Inc.2001—
−6K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−5K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−4K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek2003—
−3K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−2K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005—
−1K052670Staxx XD SystemSpine Wave, Inc.2006—
0 (this device)K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199810
199910
200010
200150
200220
200360
200440
FIG. 1 — Lineage of K080860, 2001–2008Source: 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? (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
*K003043Surgical Titanium Mesh System
Summary page 1
…substantially equivalent to the following legally marketed spinal vertebral body replacement devices: * Surgical Titanium MeshTM System (DePuy-Acromed TM , Inc., K003043) * Surgical Dynamics Mesh Cage System (United States Surgical, K003709) * Spine Wave StaXxTM XD System (Spine Wave, K…
Depuyacromed2001—
*K003709Surgical Dynamics Mesh Cage System
Summary page 1
…body replacement devices: * Surgical Titanium MeshTM System (DePuy-Acromed TM , Inc., K003043) * Surgical Dynamics Mesh Cage System (United States Surgical, K003709) * Spine Wave StaXxTM XD System (Spine Wave, K052670) Device Description The Creaspine SupStance Small Vertebral Body Rep…
United States Surgical, A Division of Tyco Healthc2001—
*K052670Staxx XD System
Summary page 1
…System (DePuy-Acromed TM , Inc., K003043) * Surgical Dynamics Mesh Cage System (United States Surgical, K003709) * Spine Wave StaXxTM XD System (Spine Wave, K052670) Device Description The Creaspine SupStance Small Vertebral Body Replacement System is a vertebral body replacement system inte…
Spine Wave, Inc.2006—

Also cleared against K003043: 25 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 7 years and passes through 4 companies; a new generation was cleared every 10 months on median.
  • 2 of the 29 ancestors have a recall of any class.
  • 25 other devices also cite its predicate K003043.

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 Small Vertebral Body Replacement System is a vertebral body replacement system intended to replace a vertebral body. The SupStance Small VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance Small 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 Small VBR System is optional.

Indications for use as stated in the FDA summary.

Also cleared against K003043

25 other devices cite the same predicate.

  • K181921Solidity Vertebral Body ReplacementUlrich Medical USA · 2018
  • K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh…Medos International SARL · 2018
  • K171704CAPRI Corpectomy Cage SystemK2m · 2017
  • K142212Pyrenees Cervical Plate SystemK2m, Inc. · 2015
  • K142030STGC-LordoticCardinal Spine, LLC · 2015
  • K142016CAPRIK2m, Inc. · 2014

More from Creaspine

2 FDA decisions under this applicant name. See the company

  • K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine · 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/K080860 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080860: Creaspine Supstance Small Vertebral Body Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080860

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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