# K192168: Idys ALIF ZP 3DTi

- Pathway: 510(k) (Traditional)
- Applicant: Clariance, Sas
- Decided: Nov 4, 2019 after 87 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 17 generations back to K003155 (2001). 209 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 215 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172083: Idys™ ALIF System, Clariance, Sas (2017) Summary page 4.
- K172465: Idys™ TLIF 3DTi Cages, Clariance, Sas (2017) Summary page 4.

## Most influential descendants
- K200920: Idys ALIF ZP 3DTi (2020), 3 descendants of its own
- K212562: Idys-C ZP 3DTi (2021), 1 descendant of its own
- K240715: Idys® C ZP 3DTi (2024), 0 descendants of its own
- K200919: Idys ALIF 3DTi (2021), 0 descendants of its own
- K202032: Idys LLIF 3DTi (2021), 0 descendants of its own

## Indications for use
The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided. The Idys® ALIF ZP 3DTi cages are intended to be used with autograft.

Source page: https://510kreport.com/device/K192168
Methodology: https://510kreport.com/methodology