# K253041: 3d Cage Cervical

- Pathway: 510(k) (Traditional)
- Applicant: Fims Co., Ltd.
- Decided: Jul 23, 2026 after 304 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: 16 generations back to K841189 (1984). 118 ancestors in all.
No later device cites it as a predicate yet.
1 of 119 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 5.

## Indications for use
The 3d Cage Cervical are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non operative treatment. The 3d Cage Cervical are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K253041
Methodology: https://510kreport.com/methodology