510(k) · Cleared
ClearedPioneer Vertebral Body Replacement Device (Pioneer 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 Jan 21, 2005 as substantially equivalent to K042268 (Ebi, L.P., 2004) after a 63-day review. Its family tree reaches back 5 generations to 1984. 1 of the 1,582 devices in its family, counting itself, has a Class I recall. 1,571 later devices descend from it.
- Decided
- Jan 21, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K841189 (1984). 10 ancestors in all. 1,571 later devices descend from it, 12 citing it directly. 1 of the 1,582 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 2 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 1 generation backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- This deviceK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
- Descendant · cites it directly · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · 2 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · cites it directly · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005
- Descendant · 3 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 4 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
Showing 5 of 1,571 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 1,571 · See all- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · cites it directly1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,405descendants
- K043479MC+ Partial VBRLdr Spine USA · 2005 · cites it directly1,214descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 3 generations on1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 4 generations on1,008descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −2 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −1 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| 0 (this device) | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) | Pioneer Surgical Technology | 2005 | — |
| +1 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +1 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| +3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +4 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 16 | 0 |
| 2009 | 8 | 0 |
| 2010 | 19 | 0 |
| 2011 | 38 | 0 |
| 2012 | 47 | 0 |
| 2013 | 58 | 0 |
| 2014 | 77 | 0 |
| 2015 | 81 | 0 |
| 2016 | 95 | 0 |
| 2017 | 122 | 0 |
| 2018 | 116 | 0 |
| 2019 | 116 | 0 |
| 2020 | 106 | 0 |
| 2021 | 105 | 1 |
| 2022 | 104 | 0 |
| 2023 | 139 | 0 |
| 2024 | 125 | 0 |
| 2025 | 101 | 0 |
| 2026 | 91 | 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 |
|---|---|---|---|
| * | K042268 | Ebi Cas Spine Spacer SystemSummary page 1…body fixation orthosis devices. The product code is MQP. The Panel code is 87. PREDICATE DEVICE: FBI CAS Spine Spacer System K042268 DEVICE The Pioneer Vertebral Spacer is a radiolucent vertebral body DESCRIPTION: repla… | 2004 |
What descends from it? (1,571)
See all 1,57112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062759 | Paramount VBR System | 2007 | 1,406 |
| K043479 | MC+ Partial VBR | 2005 | 1,214 |
| K061151 | Pioneer Vertebral Spacer (Vertebral Spacer) | 2006 | 801 |
| K112496 | Pioneer Crossfuse II Ibf/VBR System | 2011 | 604 |
| K133623 | C-PLUS | 2014 | 598 |
| K133455 | Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic | 2014 | 596 |
| K092540 | C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer | 2010 | 45 |
| 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 21 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K062759 (Innovative Spinal Technologies, Inc., 2007) has gone furthest, with 1,406 descendants of its own.
- 7 other devices also cite its predicate K042268.
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 (TL-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 (144 words)
The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (TL-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 T1-5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043206
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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