# K143518: Valeo Spacer System and Valeo II Interbody Fusion Device System

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corp.
- Decided: Oct 2, 2015 after 294 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: 2 generations back to K130177 (2013). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 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.
- K091278: Valeo Spacer System, Amedica Corp. (2010) Summary page 4.

## Most influential descendants
- K161405: Valeo II Interbody Fusion Device System (2016), 4 descendants of its own
- K192863: MONDRIAN Lumbar Interbody Fusion Cage System (2020), 3 descendants of its own
- K213641: MONDRIAN ALIF Cage with Supplementary Fixation Plate (2022), 1 descendant of its own
- K231715: MONDRIAN™ Anterior Lumbar Plate System (2024), 0 descendants of its own
- K220513: NITRO Interbody Fusion Cage System Family (2023), 0 descendants of its own

## Indications for use
Valeo® Spacer System and Valeo II™ Interbody Fusion Device System –Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System –Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System –Cervical are 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. Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System – Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System – Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K143518
Methodology: https://510kreport.com/methodology