# K202032: Idys LLIF 3DTi

- Pathway: 510(k) (Traditional)
- Applicant: Clariance, Sas
- Decided: Apr 1, 2021 after 253 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: 19 generations back to K003155 (2001). 211 ancestors in all.
No later device cites it as a predicate yet.
1 of 212 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200920: Idys ALIF ZP 3DTi, Clariance, Sas (2020) Summary page 4.
- K172083: Idys™ ALIF System, Clariance, Sas (2017) Summary page 4.
- K131178: Idys Lif Cages, Clariance (2013) Summary page 4.

## Indications for use
The Idys® LLIF 3DTi system is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous level(s) 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(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® LLIF 3DTi system is intended to be used with bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and with cleared supplemental fixation in addition to the integrated plate and screws.

Source page: https://510kreport.com/device/K202032
Methodology: https://510kreport.com/methodology