# K173080: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)

- Pathway: 510(k) (Special)
- Applicant: Huvexel Co., Ltd.
- Decided: Oct 31, 2017 after 32 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). 31 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162220: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage, Dio Medical Co., Ltd. (2016) Summary page 5.
- K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K211935: ORIO-Ti Intervertebral Body Fusion Cage System (2021), 0 descendants of its own
- K192248: Cortina™ [MAX] Lumbar Cage System (2019), 0 descendants of its own

## Indications for use
The IVA Cage (ACIF, Ti ACIF) are 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 IVA Cage (PLIF, TLIF, DLIF, ALIF,Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous 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/K173080
Methodology: https://510kreport.com/methodology