# K080024: Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Jan 24, 2008 after 20 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
No predicates in its family tree.
663 later devices descend from it; 2 cite it directly.
0 of 664 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K080024
Methodology: https://510kreport.com/methodology