# K131178: Idys Lif Cages

- Pathway: 510(k) (Traditional)
- Applicant: Clariance
- Decided: Oct 10, 2013 after 168 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: 12 generations back to K003155 (2001). 62 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113478: Plif Cage, Eisertech, LLC (2012) Summary page 2.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 2.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 2.

## Most influential descendants
- K172083: Idys™ ALIF System (2017), 7 descendants of its own
- K172465: Idys™ TLIF 3DTi Cages (2017), 6 descendants of its own
- 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

## Indications for use
The ldys1U LIF Cages are indicated for use with autologous bane graft in patients with degenerative disc disease (DOD) at one or two levels from L2 to Si. These DOD patients may also have up to Grade 1 Spondylollsthesis or retrolisthesis at the involved levels. ODD is defined as discagenic 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 the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K131178
Methodology: https://510kreport.com/methodology