# K221858: ZSFab Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Zsfab, Inc.
- Decided: Oct 14, 2022 after 109 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: 22 generations back to K841189 (1984). 332 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 337 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 4.
- K202488: ZSFab Cervical Interbody System, Zsfab, Inc. (2021) Summary page 4.
- K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology, Medtronic Sofamor Danek USA, Inc. (2019) 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 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 (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD 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/K221858
Methodology: https://510kreport.com/methodology