# K151819: Integrity Spine Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Spine Lumbar Interbody Fusion System
- Decided: Nov 10, 2015 after 127 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: 8 generations back to K841189 (1984). 28 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100042: Difusion Technologies Xiphos Interbody Fusion System, Difusion Technologies (2010) Summary page 5.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 5.

## Most influential descendants
- K171893: Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) (2017), 2 descendants of its own
- K210382: Blustone Synergy Diamond SA Cervical System (2021), 0 descendants of its own
- K203520: Blustone Synergy Interbody Fusion System (2021), 0 descendants of its own
- K181030: Rubicon Lumbar Interbody Fusion System (2018), 0 descendants of its own

## Indications for use
The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K151819
Methodology: https://510kreport.com/methodology