# K243670: Idys® LIF

- Pathway: 510(k) (Special)
- Applicant: Clariance
- Decided: Dec 31, 2024 after 34 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). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 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 5.

## Indications for use
The Idys® PLIF cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L3 to S1. The Idys® PTLIF, Idys® TLIF 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 by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K243670
Methodology: https://510kreport.com/methodology