# K180373: CancelleX Porous Titanium Lumbar Interbody Device

- Pathway: 510(k) (Traditional)
- Applicant: Xenco Medical, LLC
- Decided: Aug 24, 2018 after 193 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). 113 ancestors in all.
No later device cites it as a predicate yet.
1 of 114 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143158: Xenco Medical Lumbar Interbody System, Xenco Medical, LLC (2015) Summary page 4.
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- K152011: Lucent Intervertebral Body Fusion Device, Spinal Elements, Inc. (2016) Summary page 4.

## Indications for use
CancelleX Porous Titanium Lumbar Interbody System devices are 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 levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.

Source page: https://510kreport.com/device/K180373
Methodology: https://510kreport.com/methodology