# K130853: Idys (TM) C

- Pathway: 510(k) (Traditional)
- Applicant: Clariance
- Decided: Nov 13, 2013 after 230 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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). 68 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100214: Cornerstone PSR Cervical Interbody Fusion Device, Medtronic Sofamor Danek (2010) Summary page 1.
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 1.

## Most influential descendants
- K212562: Idys-C ZP 3DTi (2021), 1 descendant of its own
- K240715: Idys® C ZP 3DTi (2024), 0 descendants of its own

## Indications for use
The Idys C device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endiplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ldys h C device is to be used with supplemental fixation. The Idlysm C device is also required to be used with autograft and is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K130853
Methodology: https://510kreport.com/methodology