# K261031: Poseidon ST

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medinzintechnik GmbH
- Decided: Jul 10, 2026 after 102 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K841189 (1984). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142205: NuVasive X-CORE (R) Expandable VBR System, Nuvasive, Inc. (2015) Summary page 5.

## Indications for use
The POSEIDON ST is used to maintain disc space distraction and structural stability until fusion occurs in skeletally mature adults requiring thoracic/lumbar interbody replacement. POSEIDON ST is indicated for use following complete or incomplete corpectomy due to destructive damage of the vertebral body, such as that caused by tumors, fractures, or osteomyelitis, in the thoracic and lumbar regions of the spine (TH1-L5). The access is posterior, lateral, anterolateral or anterior depending on the indication. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. This device is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation. The device is intended for use in skeletally mature patients.

Source page: https://510kreport.com/device/K261031
Methodology: https://510kreport.com/methodology