# K223059: Xenco Medical InterAlign Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Xenco Medical, LLC
- Decided: Jun 7, 2023 after 250 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 1 generation back to K140786 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160313: Xenco Medical Cervical Interbody System, Xenco Medical, LLC (2016) Summary page 4.
- K140786: Xenco Medical Cervical Interbody System, Xenco Medical, LLC (2014) Summary page 4.

## Indications for use
When used as an intervertebral fusion device with bone graft, cervical: Xenco Medical InterAlign 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). When used as an intervertebral fusion device w/ integrated fixation, cervical (interbody spacer w/ provided plate, bone screws, and locking cover): Xenco Medical InterAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Xenco Medical InterAlign Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical InterAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.

Source page: https://510kreport.com/device/K223059
Methodology: https://510kreport.com/methodology