510(k) · Cleared
ClearedCreaspine Supstance Vertebral Body Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creaspine Sas · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 18, 2007 as substantially equivalent to K003043 (Depuyacromed, 2001) and 2 other predicates after a 99-day review. Its family tree reaches back 8 generations to 1984. 1 later device descends from it.
- Decided
- Dec 18, 2007
- Review
- 99 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K841189 (1984). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 1 generation backK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
- This deviceK072537 Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas · 2007
- Descendant · cites it directly · 0 of its ownK081564 Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine · 2008
Most influential descendants
Showing 1 of 1 · See all- K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −1 | K070381 | Theken VU Mesh VBR System | Theken Spine, LLC | 2007 | — |
| 0 (this device) | K072537 | Creaspine Supstance Vertebral Body Replacement System | Creaspine Sas | 2007 | — |
| +1 | K081564 | Creaspine Supstance Vertebral Body Replacement System Line Extension | Creaspine | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
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 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003043 | Surgical Titanium Mesh SystemSummary page 1…ubstantially equivalent to 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) * Theken Spine Vu Mesh VBR System (Theken… | 2001 |
| * | K003709 | Surgical Dynamics Mesh Cage SystemSummary page 1…eplacement devices: * Surgical Titanium MeshTM System (DePuy-AcromedTM, Inc., K003043) * Surgical Dynamics Mesh Cage System (United States Surgical, K003709) * Theken Spine Vu Mesh VBR System (Theken Spine, LLC, K070381) Device Description The Creaspine SupStance Vertebral Body… | 2001 |
| * | K070381 | Theken VU Mesh VBR SystemSummary page 1…uy-AcromedTM, Inc., K003043) * Surgical Dynamics Mesh Cage System (United States Surgical, K003709) * Theken Spine Vu Mesh VBR System (Theken Spine, LLC, K070381) Device Description The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replac… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081564 | Creaspine Supstance Vertebral Body Replacement System Line Extension | 2008 | 0 |
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 15 ancestors have a recall of any class.
- Of its descendants, K081564 (Creaspine, 2008) has gone furthest, with 0 descendants of its own.
- 25 other devices also cite its predicate K003043.
How does its category compare?
All MQP devicesMQP 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Creaspine SupStance Vertebral Body Replacement System (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.
https://510kreport.com/device/K072537 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072537: Creaspine Supstance Vertebral Body Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072537
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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