# K070218: Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)

- Pathway: 510(k) (Traditional)
- Applicant: Vertiflex (Tm), Incorporated
- Decided: Apr 6, 2007 after 73 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: 9 generations back to K003155 (2001). 29 ancestors in all.
60 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050861: Peek Cas, Interpore Cross Intl. (2005) Summary page 1.
- K062004: Modification to Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2006) Summary page 1.
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 1.
- K062132: Avs PL Peek Spacer System, Stryker Spine (2006) Summary page 1.
- K011037: Vertebral Spacer, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K082270: Octane Vertebral Body Replacement (VBR) System (2008), 55 descendants of its own
- K132582: Exactech Acapella One Cervical Spacer System (2014), 47 descendants of its own
- K171489: Acapella Cervical Spacer System (2017), 39 descendants of its own
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 descendants of its own
- K152099: Genesys Spine Apache® Anchored Cervical Interbody Fusion System (2016), 19 descendants of its own

## Indications for use
The VertiFlex TM PEEK VBR is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VertiFlex TM PEEK VBR 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. The interior of the VertiFlexTM PEEK VBR may be packed with bone graft.

Source page: https://510kreport.com/device/K070218
Methodology: https://510kreport.com/methodology