# K172083: Idys™ ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Clariance, Sas
- Decided: Nov 8, 2017 after 121 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: 16 generations back to K003155 (2001). 178 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K131178: Idys Lif Cages, Clariance (2013) Summary page 4.

## Most influential descendants
- K192168: Idys ALIF ZP 3DTi (2019), 5 descendants of its own
- 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

## Indications for use
The Idys™ ALIF (Anterior Lumbar Integrated Fusion) System is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of 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 levelV. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF System should be used with the integrated fixation screws provided. The Idys™ ALIF System is intended to be used with autograft.

Source page: https://510kreport.com/device/K172083
Methodology: https://510kreport.com/methodology