# K121892: Phantom Plus Ceramic Cage System

- Pathway: 510(k) (Special)
- Applicant: Amedica Corp.
- Decided: Aug 24, 2012 after 56 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: 11 generations back to K841189 (1984). 30 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 2.
- K091278: Valeo Spacer System, Amedica Corp. (2010) Summary page 2.

## Most influential descendants
- K142347: Amedica Valeo II Interbody Fusion Device (2014), 5 descendants of its own
- 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

## Indications for use
The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices indicated for use with autogenous 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). These patients should be skeletally mature and have six (6) months of nonoperative therapy. The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. The Phantom Plus Ceramic Cages-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. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom Plus Ceramic Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K121892
Methodology: https://510kreport.com/methodology