# K150455: RT2 Trabeculite Titanium Cervical Cage System

- Pathway: 510(k) (Abbreviated)
- Applicant: Rhausler, Inc.
- Decided: Nov 19, 2015 after 272 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: 6 generations back to K010530 (2001). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111272: Rhausler Plage Anterior Cervical Fusion System, Rhausler, Inc. (2011) Summary page 4.

## Indications for use
The Rhausler RT² Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment. This device is intended to be used with supplemental spinal fixation systems.

Source page: https://510kreport.com/device/K150455
Methodology: https://510kreport.com/methodology