# K261810: Vertiwedge® Intraosseous System

- Pathway: 510(k) (Special)
- Applicant: Foundation Surgical Group
- Decided: Jul 31, 2026 after 60 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: 22 generations back to K841189 (1984). 316 ancestors in all.
No later device cites it as a predicate yet.
1 of 317 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241468: Vertiwedge® Intraosseous System, Foundation Surgical Group, Inc. (2024) Summary page 5.

## Indications for use
The Vertiwedge® Intraosseous System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased or damaged vertebral body resected or excised to replace a portion and/or restore the height of a collapsed vertebral body for the treatment of previous trauma (i.e, fracture or tumor) or degenerative spine disease. The system is to be placed within the vertebral body following an osteotomy and supplemented with autograft or allograft and to be used with its contralateral staple; should a physician choose to use fewer than the maximum number of screws, then supplemental fixation must be used to augment stability. The Vertiwedge® Intraosseous System is intended to restore the integrity of the spinal column even in the absence of fusion in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K261810
Methodology: https://510kreport.com/methodology