# K251003: X-PAC® LLIF Expandable Lateral Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Expanding Innovations, Inc.
- Decided: Jun 25, 2025 after 85 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: 24 generations back to K841189 (1984). 388 ancestors in all.
No later device cites it as a predicate yet.
1 of 389 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223174: X-Pac Expandable LLIF Cage System, Expanding Innovations, Inc. (2023) Summary page 5.

## Indications for use
X-PAC® LLIF Expandable Lateral Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® LLIF Expandable Lateral Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K251003
Methodology: https://510kreport.com/methodology