# K142041: Porosteon Phusion Metal Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Porosteon, Inc.
- Decided: Dec 19, 2014 after 144 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: 2 generations back to P980048 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 4.

## Most influential descendants
- K201769: Cavetto [MAX] Cervical Cage System (2020), 0 descendants of its own

## Indications for use
The Phusion Metal Cervical Cage 1s indicated for intervertebral body fusion of the spine in skeletally mature patients. The Phusion Metal Cervical Cage 1s intended for use at one level in the cervical spine, from C3 to C7, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Phusion Metal Cervical Cage is to be used in patients who have had six weeks of non-operative treatment. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Source page: https://510kreport.com/device/K142041
Methodology: https://510kreport.com/methodology