# K132718: Integrity Spine Core System

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Spine
- Decided: Nov 18, 2013 after 80 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 10 generations back to K841189 (1984). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.
- K110733: Daytona Anterior Cervical Cage, Spinenet, LLC (2011) Summary page 1.

## Most influential descendants
- K223043: The Integrity Spine Core System (2023), 0 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level from the 02-03 disc to the C7-TI disc. ODD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K132718
Methodology: https://510kreport.com/methodology