# K122872: Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Dio Medical Co., Ltd.
- Decided: Feb 28, 2013 after 162 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: 12 generations back to K003155 (2001). 69 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111820: Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage, Bm Korea Co., Ltd. (2012) Summary page 2.

## Most influential descendants
- K132926: Velofixtm Interbody Fusion System (2014), 10 descendants of its own
- K140864: Veloxtm Interbody Fusion System (2014), 9 descendants of its own
- K172424: Velofix™ SA Cervical Cage (2017), 5 descendants of its own
- K171749: Velofix (tm) Interbody Fusion System (2017), 5 descendants of its own
- K190067: Velofix Interbody Fusion System (2019), 3 descendants of its own

## Indications for use
The Galaxy (ACIF) Peek Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T I disc. DDO is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six.(6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Galaxy (PLIF, TLIF, and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine from L2-S I in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K122872
Methodology: https://510kreport.com/methodology