# K241468: Vertiwedge® Intraosseous System

- Pathway: 510(k) (Traditional)
- Applicant: Foundation Surgical Group, Inc.
- Decided: Nov 7, 2024 after 167 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: 21 generations back to K841189 (1984). 315 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 317 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device, Blackstone Medical, Inc. (2008) Summary page 6.
- K183071: VLIFT-s Vertebral Body Replacement System, Stryker Spine (2019) Summary page 6.
- K171140: Matrixx System, Nexxt Spine, LLC (2017) Summary page 6.
- K233359: DOMINION Expandable Corpectomy System, Astura Medical (2024) Summary page 6.
- K220324: AccuFit Lateral 2-Hole Plate, Precision Spine, Inc. (2022) Summary page 6.

## Most influential descendants
- K261810: Vertiwedge® Intraosseous System (2026), 0 descendants of its own

## 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/K241468
Methodology: https://510kreport.com/methodology