# K080314: Spinal Usa Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: May 13, 2008 after 97 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
No predicates in its family tree.
40 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K133827: A-Link Z (2014), 26 descendants of its own
- K201671: A-Link Z (2021), 25 descendants of its own
- K222561: Align (2022), 14 descendants of its own
- K110442: Nanovis Intervertebral Body Fusion System (2011), 10 descendants of its own
- K140280: Forticore (2014), 9 descendants of its own

## Indications for use
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 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 to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are 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 with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Spinal USA Interbody Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.

Source page: https://510kreport.com/device/K080314
Methodology: https://510kreport.com/methodology