# K261451: ZSAlign Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: ZSFab, Inc.
- Decided: Jul 31, 2026 after 91 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: 28 generations back to K841189 (1984). 733 ancestors in all.
No later device cites it as a predicate yet.
1 of 734 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212904: SeaSpine WaveForm C Interbody System, SeaSpine Orthopedics Corporation (2021) Summary page 6.
- K242734: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System, Zsfab (2024) Summary page 6.
- K250486: Skyway Anterior Cervical Plate System, Kyocera Medical Technologies Inc. (KMTI) (2025) Summary page 6.

## Indications for use
The ZSAlign Cervical Interbody System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment prior to treatment with this device. The ZSAlign Cervical Interbody System consists of an interbody cage used in conjunction with an anterior cervical plate, available in 2-, 3-, and 4-hole configurations, and bone screws. The interbody cage component is not intended for cage-only use and must be implanted as part of the cage-plate- screw construct. Plate and bone screw fixation are required for every use of this device. The interbody cage is to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone, or a bone void filler cleared by FDA for use in intervertebral body fusion, to facilitate fusion. The ZSAlign Cervical Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1), with bone screw fixation at each treated level.

Source page: https://510kreport.com/device/K261451
Methodology: https://510kreport.com/methodology