# K222015: Integral Titanium Cervical Interbody

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Jul 5, 2023 after 362 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: 24 generations back to K841189 (1984). 281 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 283 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190380: nvc, Nvision Biomedical Technologies, Inc. (2019) Summary page 5.
- K171140: Matrixx System, Nexxt Spine, LLC (2017) Summary page 5.
- K203342: CONSTRUX Mini Ti Spacer System, Orthofix, Inc. (2021) Summary page 5.

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

## Indications for use
The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The Integral Titanium Cervical Interbody devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

Source page: https://510kreport.com/device/K222015
Methodology: https://510kreport.com/methodology