# K082698: Aleutian Ibf System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Apr 21, 2009 after 218 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K841189 (1984). 29 ancestors in all.
662 later devices descend from it; 22 cite it directly.
0 of 692 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 2.
- K063399: Aleutian Spacer System, K2m, Inc. (2007) Summary page 2.
- K080024: Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01, K2m, Inc. (2008) Summary page 2.
- (no number) Pioneer Intervertebral Fusion Device System: named in the summary without a submission number

## Most influential descendants
- 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
- K113138: Aleutian System (2012), 549 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. When used as vertebral body replacement devices the Aleutian implants are 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 implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Source page: https://510kreport.com/device/K082698
Methodology: https://510kreport.com/methodology