# K142005: SpineFab Vertebral Body Replacement (VBR) System

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Performance Materials
- Decided: Jul 10, 2015 after 352 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K841189 (1984). 27 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120570: Choice Spine Vertebral Body Replacement (VBR) Device System, Choicespine, LP (2012) Summary page 4.
- K131724: Pioneer Maxfuse Vertebral Body Replacement Device, Pioneer Surgical Technology, Inc. (2013) Summary page 4.

## Most influential descendants
- K163673: Fortilink™-C with TETRAfuse™ 3D Technology (2017), 11 descendants of its own
- K192718: Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology (2019), 5 descendants of its own
- K201453: Fortilink Cages with TiPlus Technology (2020), 4 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own
- K250827: aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (2025), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K142005
Methodology: https://510kreport.com/methodology