510(k) · Cleared
ClearedPioneer Vertebral Spacer (Vertebral Spacer)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 24, 2006 as substantially equivalent to K043206 (Pioneer Surgical Technology, 2005) after a 90-day review. Its family tree reaches back 6 generations to 1984. 1 of the 813 devices in its family, counting itself, has a Class I recall. 801 later devices descend from it.
- Decided
- Jul 24, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K841189 (1984). 11 ancestors in all. 801 later devices descend from it, 8 citing it directly. 1 of the 813 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 3 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 2 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 1 generation backK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
- This deviceK061151 Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology · 2006
- Descendant · cites it directly · 775 of its ownK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- Descendant · cites it directly · 604 of its ownK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · cites it directly · 598 of its ownK133623 C-PLUSPioneer Surgical Technology, Inc. · 2014
- Descendant · cites it directly · 596 of its ownK133455 Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
Showing 5 of 801 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 801 · See all- K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · cites it directly775descendants
- K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011 · cites it directly604descendants
- K133623C-PLUSPioneer Surgical Technology, Inc. · 2014 · cites it directly598descendants
- K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · cites it directly596descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −3 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −2 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −1 | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) | Pioneer Surgical Technology | 2005 | — |
| 0 (this device) | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer) | Pioneer Surgical Technology | 2006 | — |
| +1 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| +1 | K112496 | Pioneer Crossfuse II Ibf/VBR System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +1 | K133623 | C-PLUS | Pioneer Surgical Technology, Inc. | 2014 | — |
| +1 | K133455 | Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic | Pioneer Surgical Technology, Inc. | 2014 | 1 |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 21 | 0 |
| 2016 | 34 | 0 |
| 2017 | 51 | 0 |
| 2018 | 52 | 0 |
| 2019 | 62 | 0 |
| 2020 | 80 | 0 |
| 2021 | 67 | 1 |
| 2022 | 75 | 0 |
| 2023 | 89 | 0 |
| 2024 | 95 | 0 |
| 2025 | 78 | 0 |
| 2026 | 67 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Summary page 1…Implant, fixation, spinal intervertebral body fixation orthosis devices. The product code is MQP. The Panel code is 87. PREDICATE DEVICE: K043206 DEVICE The Pioneer Vertebral Spacer is a radiolucent vertebral body DESCRIPTION: replacement device… | 2005 |
What descends from it? (801)
See all 8018 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073177 | Pioneer Intervertebral Fusion Device System | 2008 | 775 |
| K112496 | Pioneer Crossfuse II Ibf/VBR System | 2011 | 604 |
| K133623 | C-PLUS | 2014 | 598 |
| K133455 | Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic | 2014 | 596 |
| K131724 | Pioneer Maxfuse Vertebral Body Replacement Device | 2013 | 73 |
| K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | 2015 | 12 |
| K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | 2017 | 11 |
| K063464 | Atlas Spine Vertebral Body Replacement | 2007 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K073177 (Pioneer Surgical Technology, 2008) has gone furthest, with 775 descendants of its own.
- 11 other devices also cite its predicate K043206.
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.
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 Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine.…
Read the full statement (145 words)
The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061151: Pioneer Vertebral Spacer (Vertebral Spacer).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061151
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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