# K120796: Superdimension Nitinol/Gold Fiducial Marker

- Pathway: 510(k) (Traditional)
- Applicant: Superdimension, Inc.
- Decided: Oct 26, 2012 after 225 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K874787 (1987). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031206: Radiomed Soft Tissue Marker, Radiomed Corp. (2003) Summary page 1.
- K100267: Fleximarc, Model CM-0.9-2-10-GG-L, Cortex Manufacturing, Inc. (2010) Summary page 1.
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560, Somatex Medical Technologies GmbH (2010) Summary page 1.

## Most influential descendants
- K170570: Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - Lung (2018), 0 descendants of its own

## Indications for use
The superDimension superLock Cobra is intended for use to radiographically mark soft tissue for future surgical therapeutic procedures. The superLock Cobra is contraindicated as follows: - No more than 10 devices should be used per patient - Devices should not be used in an MRI machine with magnetic coils that exceed 3T

Source page: https://510kreport.com/device/K120796
Methodology: https://510kreport.com/methodology