# K200919: Idys ALIF 3DTi

- Pathway: 510(k) (Traditional)
- Applicant: Clariance
- Decided: Apr 12, 2021 after 371 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: 18 generations back to K003155 (2001). 210 ancestors in all.
No later device cites it as a predicate yet.
1 of 211 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.
- K192168: Idys ALIF ZP 3DTi, Clariance, Sas (2019) Summary page 4.

## Indications for use
The Idyse ALIF 3DTi (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 level. 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 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

Source page: https://510kreport.com/device/K200919
Methodology: https://510kreport.com/methodology