# K232150: ZSFab Cervical Interbody System

- Pathway: 510(k) (Special)
- Applicant: Zsfab, Inc.
- Decided: Aug 18, 2023 after 30 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: 21 generations back to K841189 (1984). 227 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 232 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202488: ZSFab Cervical Interbody System, Zsfab, Inc. (2021) Summary page 4.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.
- K222004: INTEGRATE -C Interbody Fusion System, Happe Spine (2023) Summary page 4.

## Most influential descendants
- 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 ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat 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-Tl. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine. Implants having a lordotic angulation > 10° are required to be used with an anterior cervical plate as the form of supplemental fixation.

Source page: https://510kreport.com/device/K232150
Methodology: https://510kreport.com/methodology