# K031914: Spinal Concepts, Inc. Cadence and Fortitude

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Jul 12, 2003 after 22 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: 2 generations back to K010530 (2001). 3 ancestors in all.
1,530 later devices descend from it; 2 cite it directly.
2 of 1,534 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010530: Geo Structure, Interpore Cross Intl. (2001)
- K020048: Modification to Geo Structure, Interpore Cross Intl. (2002) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000)

## Most influential descendants
- K033517: Spinal Concepts Inc. Cadence and Traxis (2004), 1,528 descendants of its own
- K062759: Paramount VBR System (2007), 1,406 descendants of its own
- 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

## Indications for use
Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (Le., partial or total vertebrectomy procedures) due to tumor or trauma (Le., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Source page: https://510kreport.com/device/K031914
Methodology: https://510kreport.com/methodology