# K172330: Blustone Synergy Silica System

- Pathway: 510(k) (Traditional)
- Applicant: Blustone Synergy
- Decided: Dec 21, 2017 after 141 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: 8 generations back to K841189 (1984). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 4.

## Indications for use
The Blustone Synergy Silica System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. 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 autograft or allograft bone.

Source page: https://510kreport.com/device/K172330
Methodology: https://510kreport.com/methodology