# K222004: INTEGRATE -C Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Happe Spine
- Decided: Apr 28, 2023 after 295 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: 16 generations back to K841189 (1984). 81 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173030: Vertera Spine Cohere Cervical Interbody Fusion Device, Nu Vasive, Incorporated (2017) Summary page 5.
- K133784: Vista-S Device, Associated Instrumentation, Zimmer Trabecular Metal Technology (2014) Summary page 5.
- K172484: A-CIFT SoloFuse, Spinefrontier, Inc. (2018) Summary page 5.

## Most influential descendants
- K232150: ZSFab Cervical Interbody System (2023), 4 descendants of its own
- K242734: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System (2024), 3 descendants of its own
- K252610: ZSFab Lumbar Interbody System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own
- K260549: ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (2026), 0 descendants of its own

## Indications for use
The INTEGRATE™-C Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The INTEGRATE™-C Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The INTEGRATE™-C Interbody Fusion System is intended to be used with supplemental fixation. The INTEGRATE™-C Interbody Fusion System is designed for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Nonoperative treatment prior to treatment with INTEGRATE™-C Interbody Fusion System is six (6) weeks. INTEGRATE™-C Interbody Fusion Systems are to be implemented via an open anterior approach.

Source page: https://510kreport.com/device/K222004
Methodology: https://510kreport.com/methodology