# K063399: Aleutian Spacer System

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Feb 23, 2007 after 106 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: 8 generations back to K841189 (1984). 27 ancestors in all.
663 later devices descend from it; 2 cite it directly.
0 of 691 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051454: Aleutian Spacer System, K2m, LLC (2005) Summary page 1.

## Most influential descendants
- K082698: Aleutian Ibf System (2009), 662 descendants of its own
- K101302: Aleutian Ibf System (2010), 595 descendants of its own
- K110843: Aleutian Spacer System (2011), 589 descendants of its own
- K103169: Aleuttian (2011), 572 descendants of its own
- K130699: Aleutian Spinal System (2013), 570 descendants of its own

## Indications for use
The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System 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 Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental fixation system that may be used with this implant is the Denali Spinal System, Denali Deformity and Mesa Spinal system.

Source page: https://510kreport.com/device/K063399
Methodology: https://510kreport.com/methodology