# K013382: Modification to: Stackable Cage System

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Nov 7, 2001 after 26 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: 1 generation back to K001340 (2000). 1 ancestor in all.
1,110 later devices descend from it; 4 cite it directly.
1 of 1,112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.

## Most influential descendants
- K090899: Depuy Spine Lateral System (2009), 932 descendants of its own
- K041617: Stalif TT (2004), 929 descendants of its own
- K093242: Patriot Transcontinental Llif Spacer (2009), 921 descendants of its own
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own
- K102293: Caliber Spacer (2011), 869 descendants of its own

## Indications for use
The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 - L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Stackable Cage is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Stackable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, Profile).

Source page: https://510kreport.com/device/K013382
Methodology: https://510kreport.com/methodology