# K240715: Idys® C ZP 3DTi

- Pathway: 510(k) (Special)
- Applicant: Clariance
- Decided: Mar 22, 2024 after 7 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 20 generations back to K003155 (2001). 244 ancestors in all.
No later device cites it as a predicate yet.
1 of 245 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212562: Idys-C ZP 3DTi, Clariance, SA (2021) Summary page 4.
- K132029: Vault-C Intervertebral Body Fusion Device, Spinal USA (2013) Summary page 4.

## Indications for use
The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys®-C ZP 3DTi device must be filled with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K240715
Methodology: https://510kreport.com/methodology