# K201145: X-Pac Expandable Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Expanding Innovations, Inc.
- Decided: Sep 10, 2020 after 134 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: 15 generations back to K841189 (1984). 39 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152539: SpineView X-Pac Expandable Lumbar Cage System, Spine View, Inc. (2016) Summary page 4.
- K160856: SpineView X-Pac Expandable Lumbar Cage System, Spine View, Inc. (2016) Summary page 4.
- K083714: Endoskeleton TT Interbody Fusion Device (Ibd), Titan Spine, LLC (2009) Summary page 4.

## Most influential descendants
- K203802: X-Pac Expandable Lumbar Cage System (2021), 3 descendants of its own
- K220655: X-Pac Expandable Lumbar Cage System (2022), 2 descendants of its own
- K222797: X-Pac Expandable Lumbar Cage System (2022), 1 descendant 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 Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

Source page: https://510kreport.com/device/K201145
Methodology: https://510kreport.com/methodology