# K223174: X-Pac Expandable LLIF Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Expanding Innovations, Inc.
- Decided: Feb 14, 2023 after 126 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: 23 generations back to K841189 (1984). 387 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 391 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220581: Zavation eZspand Interbody System, Zavation Medical Products, LLC (2022) Summary page 4.

## Most influential descendants
- K251003: X-PAC® LLIF Expandable Lateral Cage System (2025), 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
- K250602: X-PAC® N-GAGE™ Lumbar Plate System (2025), 0 descendants of its own

## Indications for use
The Expanding Innovations X-Pac Expandable LLIF 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 to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. The X-Pac Expandable LLIF 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/K223174
Methodology: https://510kreport.com/methodology