# K062759: Paramount VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Spinal Technologies, Inc.
- Decided: Jan 12, 2007 after 119 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). 21 ancestors in all.
1,406 later devices descend from it; 1 cites it directly.
1 of 1,428 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033517: Spinal Concepts Inc. Cadence and Traxis, Spinal Concepts, Inc. (2004) Summary page 1.
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer), Pioneer Surgical Technology (2005) Summary page 1.
- K042930: Spacevision Cage System, Spine Vision, Inc. (2004) Summary page 1.

## Most influential descendants
- K072120: Paramount Intervertebral Body Fusion Device (2007), 1,405 descendants of its own
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own
- K080083: Intrepid Spinal System (2008), 932 descendants of its own
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own

## Indications for use
The ParamountTM VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ParamountTM VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the ParamountTM Pedicle Screw System.

Source page: https://510kreport.com/device/K062759
Methodology: https://510kreport.com/methodology