# K071614: Fiducial Markers

- Pathway: 510(k) (Traditional)
- Applicant: Civco
- Decided: Sep 11, 2007 after 90 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 11 cite it directly.
2 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102506: Mixed Media Marker (2011), 25 descendants of its own
- K120804: Cianna Medical Tissue Marker and Delivery System (2013), 15 descendants of its own
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm (2016), 13 descendants of its own
- K163541: Magseed Magnetic Marker System (2017), 12 descendants of its own
- K143484: BioZorb Marker (2015), 7 descendants of its own

## Recalls of this device
- Feb 28, 2008 · Not classified · Z-1614-2008: Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.
- Feb 28, 2008 · Not classified · Z-1613-2008: Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers.

## Indications for use
The Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. Specifically, they can be use in intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.

Source page: https://510kreport.com/device/K071614
Methodology: https://510kreport.com/methodology