# K172465: Idys™ TLIF 3DTi Cages

- Pathway: 510(k) (Traditional)
- Applicant: Clariance, Sas
- Decided: Dec 15, 2017 after 123 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: 15 generations back to K841189 (1984). 116 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 123 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131178: Idys Lif Cages, Clariance (2013) Summary page 4.
- K150481: Cascadia Interbody System, K2m, Inc. (2015) 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™ TLIF 3DTi cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K172465
Methodology: https://510kreport.com/methodology