# K183197: PYRAMESH™ Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Apr 4, 2019 after 136 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: 11 generations back to K003155 (2001). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011406: Spinal Mesh System, Medtronic Sofamor Danek, Inc. (2001) Summary page 4.
- K091883: T2 Spinal System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 4.
- K052931: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2005) Summary page 4.
- K041389: Synthes Contoured Synmesh Spacer, Synthes Spine (2004) Summary page 5.

## Indications for use
The PYRAMESH™ implants are for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. When used for Spinal Indications PYRAMESH™ implants is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon's discretion.

Source page: https://510kreport.com/device/K183197
Methodology: https://510kreport.com/methodology