# K183259: Idys™ TLIF TiVac

- Pathway: 510(k) (Traditional)
- Applicant: Clariance, Sas
- Decided: Mar 1, 2019 after 100 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: 13 generations back to K003155 (2001). 70 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131178: Idys Lif Cages, Clariance (2013) Summary page 4.
- K150061: Lucent; Lucent Ti-Bond Systems, Spinal Elements, Inc. (2015) Summary page 4.

## Most influential descendants
- K191263: Idys ALIF TiVac (2019), 0 descendants of its own

## Indications for use
The Idys™ TLIF TiVac cages are indicated for use with autologous 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 devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation, which has been cleared by FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K183259
Methodology: https://510kreport.com/methodology