# K180347: 3d Cage

- Pathway: 510(k) (Traditional)
- Applicant: Fims Co., Ltd.
- Decided: Oct 28, 2019 after 627 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: 20 generations back to K841189 (1984). 266 ancestors in all.
No later device cites it as a predicate yet.
1 of 267 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.
- K111820: Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage, Bm Korea Co., Ltd. (2012) Summary page 4.
- K171351: Posterior Spine Truss System (PSTS) Interbody Fusion Device, 4Web, Inc. (2017) Summary page 4.

## Indications for use
The 3d Cage is an intervertebral body fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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 months of non-operative therapy. The device is indicated to be used with a supplemental fixation system and autograft bone.

Source page: https://510kreport.com/device/K180347
Methodology: https://510kreport.com/methodology