# K162220: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage

- Pathway: 510(k) (Traditional)
- Applicant: Dio Medical Co., Ltd.
- Decided: Nov 21, 2016 after 105 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
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Galaxy PEEK Cage: named in the summary without a submission number
- (no number) Synster Cage: named in the summary without a submission number
- (no number) VENTUS Lumbar Intervertebral Body Fusion Cage System: named in the summary without a submission number
- (no number) Inness PEEK Cage: named in the summary without a submission number
- (no number) AnyPlus PEEK Cage: named in the summary without a submission number

## Most influential descendants
- K172419: Velofix™ TLIF Cage (2017), 2 descendants of its own
- K173080: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (2017), 2 descendants of its own
- K212038: K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (2021), 1 descendant of its own
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own

## Indications for use
The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device 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 DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD 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/K162220
Methodology: https://510kreport.com/methodology