# K200920: Idys ALIF ZP 3DTi

- Pathway: 510(k) (Special)
- Applicant: Clariance, Sas
- Decided: May 29, 2020 after 53 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.
3 later devices descend from it; 2 cite it directly.
1 of 214 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192168: Idys ALIF ZP 3DTi, Clariance, Sas (2019) Summary page 4.
- K172083: Idys™ ALIF System, Clariance, Sas (2017) Summary page 4.

## Most influential descendants
- K212562: Idys-C ZP 3DTi (2021), 1 descendant of its own
- K240715: Idys® C ZP 3DTi (2024), 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 bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion

Source page: https://510kreport.com/device/K200920
Methodology: https://510kreport.com/methodology