# K243673: Xenco Medical CancelleX Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Xenco Medical, LLC
- Decided: Jan 29, 2025 after 63 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 25 generations back to K841189 (1984). 283 ancestors in all.
No later device cites it as a predicate yet.
1 of 284 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140786: Xenco Medical Cervical Interbody System, Xenco Medical, LLC (2014) Summary page 5.
- K222015: Integral Titanium Cervical Interbody, Nvision Biomedical Technologies, Inc. (2023) Summary page 5.

## Indications for use
Xenco Medical CancelleX Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device. The device is intended to be used with supplemental fixation (e.g. anterior plate system).

Source page: https://510kreport.com/device/K243673
Methodology: https://510kreport.com/methodology