# K081673: Dyn-Alif Anterolateral Intervertebral Body Fusion Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Ionics Medical Corp.
- Decided: Nov 14, 2008 after 154 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: 2 generations back to K010930 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- K983667: Ionics Levante Intervertebral Pillar, Expandable, Ionics Medical Corp. (2000) Summary page 1.
- K010930: Lift VB Spinal System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K024049: Verte-Span Spinal System, Medtronic Sofamor Danek, Inc. (2003) Summary page 1.

## Indications for use
The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion. The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to SI 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 to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K081673
Methodology: https://510kreport.com/methodology