# K050449: Quantum Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Orthopedics, Inc.
- Decided: Jul 7, 2005 after 135 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: 6 generations back to K841189 (1984). 18 ancestors in all.
197 later devices descend from it; 7 cite it directly.
0 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040284: Sustain Radiolucent Spacer, Globus Medical, Inc. (2004) Summary page 2.
- K033517: Spinal Concepts Inc. Cadence and Traxis, Spinal Concepts, Inc. (2004) Summary page 2.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 2.
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 2.
- K041617: Stalif TT, Surgicraft, Ltd. (2004) Summary page 2.
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 2.

## Most influential descendants
- K062151: Box Peek VBR System (2006), 175 descendants of its own
- 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

## Indications for use
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

Source page: https://510kreport.com/device/K050449
Methodology: https://510kreport.com/methodology