# K133418: Integra Expandable Interverebral Body Fusion Device (Ibd) System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: May 1, 2014 after 175 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: 11 generations back to K841189 (1984). 23 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 1.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 1.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K112323: Cardia-Cath, Millar Instruments, Inc. (2011). Our reading of the summary gave K112323, FDA’s number for Cardia-Cath (Millar Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Caliber Spacers”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K193418: SeaSpine Skipjack System (2020), 4 descendants of its own
- K212540: Explorer TO System (2021), 3 descendants of its own
- K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (2024), 2 descendants of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own
- K251617: X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (2025), 0 descendants of its own

## Indications for use
The Integra Expandable Intervertebral Body Fusion Device (IBD) System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

Source page: https://510kreport.com/device/K133418
Methodology: https://510kreport.com/methodology