# K171495: Zyston Strut Open Titanium Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet Spine, Inc.
- Decided: Feb 12, 2018 after 266 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: 21 generations back to K841189 (1984). 169 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 171 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), 4Web, Inc. (2015) Summary page 4.
- K162262: Tritanium® PL Cage, Stryker (2016) Summary page 4.
- K153695: Biomet Spine Fusion System, Biomet Spine, LLC (2016) Summary page 4.

## Most influential descendants
- K251479: Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) (2025), 0 descendants of its own

## Indications for use
When used as a lumbar intervertebral body fusion device, the Zyston Strut Open Titanium Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Zyston Strut Open Titanium Interbody Spacer System is to be implanted via a posterior approach and is to be combined with supplemental fixation. The titanium fusion devices are not indicated for vertebral body replacement.

Source page: https://510kreport.com/device/K171495
Methodology: https://510kreport.com/methodology