# K252610: ZSFab Lumbar Interbody System

- Pathway: 510(k) (Special)
- Applicant: Zsfab, Inc.
- Decided: Nov 25, 2025 after 99 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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). 383 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K221858: ZSFab Lumbar Interbody System, Zsfab, Inc. (2022) Summary page 6.
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 6.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 6.

## Most influential descendants
- K260549: ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (2026), 0 descendants of its own

## Indications for use
The ZSFab Lumbar lnterbody 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 lnterbody 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 lnterbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar lnterbody 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/K252610
Methodology: https://510kreport.com/methodology