# K192145: Galileo Vertebral Body Replacement Device

- Pathway: 510(k) (Traditional)
- Applicant: Bright Spine
- Decided: Apr 21, 2020 after 257 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- 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: 22 generations back to K841189 (1984). 299 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 301 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183588: Choice Spine Hawkeye Vertebral Body Replacement (VBR) System, Choicespine (2019) Summary page 4.
- K171140: Matrixx System, Nexxt Spine, LLC (2017) Summary page 4.
- K103488: Concorde Bullet Cage System, Johnson and Johnson (2011) Summary page 4.

## Most influential descendants
- K221542: Galileo Vertebral Body Replacement Device (2023), 0 descendants of its own

## Indications for use
When used as a single-level partial vertebral body replacement device, the Galileo™ devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patients for the partial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors, or trauma/fracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galileo™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

Source page: https://510kreport.com/device/K192145
Methodology: https://510kreport.com/methodology