# K161405: Valeo II Interbody Fusion Device System

- Pathway: 510(k) (Special)
- Applicant: Amedica Corp.
- Decided: Aug 19, 2016 after 91 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 K841189 (1984). 46 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121892: Phantom Plus Ceramic Cage System, Amedica Corp. (2012) Summary page 4.
- K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 4.
- K143518: Valeo Spacer System and Valeo II Interbody Fusion Device System, Amedica Corp. (2015) Summary page 4.

## Most influential descendants
- 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 II Interbody Fusion Devices - 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 II Interbody Fusion Devices-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 C7-T1 disc space using autograft or allogenicbone graft comprised of cancellous and/or corticocancelous bone graft. Valeo II Interbody Fusion Devices-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 II Interbody Fusion Devices-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 II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems. 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/K161405
Methodology: https://510kreport.com/methodology