# K033517: Spinal Concepts Inc. Cadence and Traxis

- Pathway: 510(k) (Special)
- Applicant: Spinal Concepts, Inc.
- Decided: Feb 18, 2004 after 103 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010530 (2001). 4 ancestors in all.
1,528 later devices descend from it; 6 cite it directly.
2 of 1,533 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031914: Spinal Concepts, Inc. Cadence and Fortitude, Spinal Concepts, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K080083: Intrepid Spinal System (2008), 932 descendants of its own

## Recalls of this device
- Apr 1, 2004 · Not classified · Z-1343-04: Handle becomes loose after repeated use.

## Indications for use
Cadence and TraXis 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 (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., 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/K033517
Methodology: https://510kreport.com/methodology