# K221542: Galileo Vertebral Body Replacement Device

- Pathway: 510(k) (Special)
- Applicant: Bright Spine
- Decided: Jan 13, 2023 after 231 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: 23 generations back to K841189 (1984). 300 ancestors in all.
No later device cites it as a predicate yet.
1 of 301 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192145: Galileo Vertebral Body Replacement Device, Bright Spine (2020) Summary page 4.

## 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 traumal/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/K221542
Methodology: https://510kreport.com/methodology