510(k) · Cleared
ClearedPioneer Maxfuse Vertebral Body Replacement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 24, 2013 as substantially equivalent to K061151 (Pioneer Surgical Technology, 2006) and 2 other predicates after a 195-day review. Its family tree reaches back 7 generations to 1984. 73 later devices descend from it.
- Decided
- Dec 24, 2013
- Review
- 195 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K841189 (1984). 20 ancestors in all. 73 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 4 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 3 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 2 generations backK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
- 1 generation backK061151 Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology · 2006
- This deviceK131724 Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc. · 2013
- Descendant · cites it directly · 58 of its ownK142030 STGC-LordoticCardinal Spine, LLC · 2015
- Descendant · 2 generations on · 57 of its ownK152568 C-VBRCardinal Spine, LLC · 2016
- Descendant · 3 generations on · 55 of its ownK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- Descendant · 4 generations on · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 5 generations on · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K142030STGC-LordoticCardinal Spine, LLC · 2015 · cites it directly58descendants
- K152568C-VBRCardinal Spine, LLC · 2016 · 2 generations on57descendants
- K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017 · 3 generations on55descendants
- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 4 generations on28descendants
- K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −4 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −3 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −2 | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) | Pioneer Surgical Technology | 2005 | — |
| −1 | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer) | Pioneer Surgical Technology | 2006 | — |
| 0 (this device) | K131724 | Pioneer Maxfuse Vertebral Body Replacement Device | Pioneer Surgical Technology, Inc. | 2013 | — |
| +1 | K142030 | STGC-Lordotic | Cardinal Spine, LLC | 2015 | — |
| +2 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| +3 | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| +4 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +5 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 11 | 0 |
| 2025 | 9 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer)Summary page 1…ification Spinal Vertebral Body Replacement Device Name: Classification: 21 CFR 888.3060 - Product code MQP, Class 11 Predicate Pioneer Vertebral Spacer (1(061151I) IDevices: DePuy Spine Bengal Stackable Cage System (K073649) NuVasive Mesh VI3R (K032476) Descriptio… | 2006 |
| * | K073649 | Bengal Stackable Cage SystemSummary page 1…ation: 21 CFR 888.3060 - Product code MQP, Class 11 Predicate Pioneer Vertebral Spacer (1(061151I) IDevices: DePuy Spine Bengal Stackable Cage System (K073649) NuVasive Mesh VI3R (K032476) Description: 1The MaxFuse VBR System is a radidlucent, multilevel corpecto… | 2008 |
| * | K032476 | Nuvasive MeshSummary page 1…ass 11 Predicate Pioneer Vertebral Spacer (1(061151I) IDevices: DePuy Spine Bengal Stackable Cage System (K073649) NuVasive Mesh VI3R (K032476) Description: 1The MaxFuse VBR System is a radidlucent, multilevel corpectomy system with VBR devices in… | 2003 |
What descends from it? (73)
See all 732 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K142030 (Cardinal Spine, LLC, 2015) has gone furthest, with 58 descendants of its own.
- 7 other devices also cite its predicate K061151.
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. 2013, 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 MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., TI-LS) to replace a diseased vertebral body resected or excised for the treatment of tumors. to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxF *useVBR System is also indicated for treating fractures of the thomacic and lumbar spine. The MaxFuse VBR System isdesigned to restore the…
Read the full statement (138 words)
The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., TI-LS) to replace a diseased vertebral body resected or excised for the treatment of tumors. to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxF *useVBR System is also indicated for treating fractures of the thomacic and lumbar spine. The MaxFuse VBR System isdesigned to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of futsion for a prolonged period.
The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131724: Pioneer Maxfuse Vertebral Body Replacement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131724
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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