# K260549: ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

- Pathway: 510(k) (Special)
- Applicant: Zsfab, Inc.
- Decided: Apr 24, 2026 after 65 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: 25 generations back to K841189 (1984). 384 ancestors in all.
No later device cites it as a predicate yet.
1 of 385 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242734: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System, Zsfab (2024) Summary page 6.
- K252610: ZSFab Lumbar Interbody System, Zsfab, Inc. (2025) Summary page 6.

## 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 clinical image (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. 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. The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DOD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar 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 lumbosacral spine.

Source page: https://510kreport.com/device/K260549
Methodology: https://510kreport.com/methodology