# K062004: Modification to Quantum Vertebral Body Replacement

- Pathway: 510(k) (Special)
- Applicant: Quantum Orthopedics, Inc.
- Decided: Aug 15, 2006 after 29 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
No predicates in its family tree.
64 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Quantum Vertebral Body Replacement: named in the summary without a submission number

## Most influential descendants
- K070218: Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) (2007), 60 descendants of its own
- 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

## Indications for use
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (TI-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/K062004
Methodology: https://510kreport.com/methodology