# K152460: Rectangular Corpectomy Cage

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Dec 22, 2015 after 116 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: 4 generations back to K841189 (1984). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091426: Cervicore Corpectomy Cage, Verticor, Ltd. (2009) Summary page 4.
- K103320: Synthes XRL, Synthes Spine Co.Lp (2011) Summary page 4.
- K072029: Phenix Vertebral Body Replacement, New Business Development, LLC (2007) Summary page 4.

## Indications for use
The Rectangular Corpectomy Cage is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Rectangular Corpectomy Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K152460
Methodology: https://510kreport.com/methodology