# K173453: Valeo® C+CSC with Lumen Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corp.
- Decided: Mar 5, 2018 after 119 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: 2 generations back to P980048 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142264: Valeo C Spacer System, Valeo II C IBF Device, Amedica Corp. (2014) Summary page 4.
- K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 4.

## Indications for use
The VALEO® C+CSC with Lumen Interbody Fusion Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo® C+CSC with Lumen Interbody Fusion Device is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. VALEO® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K173453
Methodology: https://510kreport.com/methodology