# K140786: Xenco Medical Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Xenco Medical, LLC
- Decided: Sep 3, 2014 after 156 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243673: Xenco Medical CancelleX Cervical Interbody System (2025), 0 descendants of its own
- K223059: Xenco Medical InterAlign Cervical Interbody System (2023), 0 descendants of its own

## Indications for use
Xenco Medical 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/K140786
Methodology: https://510kreport.com/methodology