# K082801: Phantom Plus Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Us Spine
- Decided: Dec 22, 2008 after 89 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: 10 generations back to K841189 (1984). 28 ancestors in all.
643 later devices descend from it; 13 cite it directly.
1 of 672 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 1.
- K080401: Shell Cage, Wave Cage, Loop Cage, Advanced Medical Technologies AG (2008) Summary page 1.

## Most influential descendants
- K100889: Endoskeleton TC (2010), 455 descendants of its own
- K093093: Small Plateau Spacer System (2010), 393 descendants of its own
- K111264: Cornerstone (R) PSR Cervical Fusion System (2011), 331 descendants of its own
- K112444: Anatomic Peek Cervical Fusion System (2011), 324 descendants of its own
- K121649: Construx Mini Peek TI Spacer System (2012), 289 descendants of its own

## Indications for use
The PhantomTM Plus 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 SI. 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 PhantomTM Plus Cage System- Lumbar is to be filled with autogenous bone graft material. The PhantomTM Plus Cages- Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. PhantorrTm Plus 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. PhantomTMm Plus Cages-Cervical are used to facilitate int'ervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. PhantonmTM Plus 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/K082801
Methodology: https://510kreport.com/methodology