# K062151: Box Peek VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Dec 22, 2006 after 148 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: 7 generations back to K841189 (1984). 23 ancestors in all.
175 later devices descend from it; 2 cite it directly.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043316: Rabea Spinal Implant, Signus Medizintechnik GmbH (2005) Summary page 1.
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System, Theken Surgical,Llc (2004) Summary page 1.
- K050553: Novel VBR Spinal System, Alphatec/Nexmed (2005) Summary page 1.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K050449: Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2005) Summary page 1.

## Most influential descendants
- K140142: Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) (2014), 172 descendants of its own
- K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (2016), 171 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Indications for use
The Innovasis BoXTM peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis ExcellaTM Pedicle Screw System. The interior of the BoxTM system can be packed with allograft or autograft. BoxTM implants are intended to be used in pairs.

Source page: https://510kreport.com/device/K062151
Methodology: https://510kreport.com/methodology