510(k) · Cleared
ClearedSpineFab Vertebral Body Replacement (VBR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Performance Materials · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 10, 2015 as substantially equivalent to K120570 (Choicespine, LP, 2012) and 1 other predicate after a 352-day review. Its family tree reaches back 8 generations to 1984. 13 later devices descend from it.
- Decided
- Jul 10, 2015
- Review
- 352 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 27 ancestors in all. 13 later devices descend from it, 2 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 backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 5 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 4 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 3 generations backK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
- 2 generations backK061151 Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology · 2006
- 1 generation backK131724 Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc. · 2013
- This deviceK142005 SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials · 2015
- Descendant · cites it directly · 11 of its ownK163673 Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
- Descendant · 4 generations on · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
- Descendant · 5 generations on · 2 of its ownK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc. · 2017 · cites it directly11descendants
- K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019 · 2 generations on5descendants
- K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020 · 3 generations on4descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · 4 generations on3descendants
- K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc. · 2025 · 5 generations on2descendants
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 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −5 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −4 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −3 | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) | Pioneer Surgical Technology | 2005 | — |
| −2 | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer) | Pioneer Surgical Technology | 2006 | — |
| −1 | K131724 | Pioneer Maxfuse Vertebral Body Replacement Device | Pioneer Surgical Technology, Inc. | 2013 | — |
| 0 (this device) | K142005 | SpineFab Vertebral Body Replacement (VBR) System | Oxford Performance Materials | 2015 | — |
| +1 | K163673 | Fortilink™-C with TETRAfuse™ 3D Technology | Rti Surgical, Inc. | 2017 | — |
| +2 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| +3 | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | — |
| +4 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
| +5 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar… | Carlsmed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K120570 | Choice Spine Vertebral Body Replacement (VBR) Device SystemSummary page 4…R 888.3060 Review Panel: Orthopedic Medical Device Classification: Class 2 Product Code: MQP Predicate Devices: the Choice Spine Vertebral Body Replacement (VBR) System (K120570) (primary) and the Pioneer Surgical Technology, Inc. MaxFuse VBR System (K131724). Description of the Device The SpineFab® VBR… | 2012 |
| * | K131724 | Pioneer Maxfuse Vertebral Body Replacement DeviceSummary page 4…t Code: MQP Predicate Devices: the Choice Spine Vertebral Body Replacement (VBR) System (K120570) (primary) and the Pioneer Surgical Technology, Inc. MaxFuse VBR System (K131724). Description of the Device The SpineFab® VBR implant is a non‐custom implant. The SpineFab® VBR Implants consist of 48 differe… | 2013 |
What descends from it? (13)
See all 132 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 31 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K163673 (Rti Surgical, Inc., 2017) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K120570.
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. 2015, 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?
SpineFab® Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142005: SpineFab Vertebral Body Replacement (VBR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142005
Report an extraction error
Are you the manufacturer?
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