# K033663: Spinal Concepts Inc. Coda

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: May 27, 2004 after 188 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: 5 generations back to K841189 (1984). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022793: Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.

## Most influential descendants
- K050997: Expanse Vertebral Body Replacement Device (2005), 0 descendants of its own

## Indications for use
Coda is a vertebral body replacement device 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). Coda 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. Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.

Source page: https://510kreport.com/device/K033663
Methodology: https://510kreport.com/methodology