# K153356: Spine Innovation Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Innovation, LLC
- Decided: Jan 14, 2016 after 55 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: 12 generations back to K003155 (2001). 84 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123913: Latis Spacer, Globus Medical, Inc. (2013) Summary page 4.
- K113478: Plif Cage, Eisertech, LLC (2012) Summary page 4.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 4.
- K130548: Epicage Interbody Fusion Device, Alphatec Spine, Inc. (2013) Summary page 4.
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 4.

## Most influential descendants
- K253266: Titanium Interbody System (2026), 0 descendants of its own

## Indications for use
The Spine Innovation Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Spine Innovation Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Spine Innovation Interbody System.

Source page: https://510kreport.com/device/K153356
Methodology: https://510kreport.com/methodology