# K092193: Spinal Usa Interbody Cages

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Sep 25, 2009 after 66 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.
647 later devices descend from it; 11 cite it directly.
1 of 648 devices in its family (counting itself) has 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
- K131082: Interform Interbody Cage System (2013), 595 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 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 for the ALIF, LLIF, TLIF, T-PLIF and PLIF system. Two devices are used per intervertebral space for the PLIF system. The Spinal USA Interbody Fusion Device ALIF, LLIF, TLIF, T-PLIF and PLIF System 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 to be used with supplemental fixation and autogenous 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 Stabilizer RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The Stabilizer RPIF device is not meant for stand alone use.

Source page: https://510kreport.com/device/K092193
Methodology: https://510kreport.com/methodology