# K162133: VerteFIT Corpectomy Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA, Inc.
- Decided: May 16, 2017 after 288 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: 11 generations back to K003155 (2001). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111294: Santorini Spinal System, K2m, Inc. (2012) Summary page 4.
- K121107: Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R), Globus Medical, Inc. (2012) Summary page 4.

## Indications for use
The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to LS5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Source page: https://510kreport.com/device/K162133
Methodology: https://510kreport.com/methodology