# K091743: Sec VBR

- Pathway: 510(k) (Traditional)
- Applicant: Innvotec Surgical, Inc.
- Decided: Nov 2, 2009 after 139 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K110153: SFC Vertebral Body Replacement (2011), 0 descendants of its own

## Indications for use
The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body. The Innvotec Surgical SEC 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 Innvotec Surgical SEC VBR is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.

Source page: https://510kreport.com/device/K091743
Methodology: https://510kreport.com/methodology