# K100267: Fleximarc, Model CM-0.9-2-10-GG-L

- Pathway: 510(k) (Traditional)
- Applicant: Cortex Manufacturing, Inc.
- Decided: Feb 24, 2010 after 26 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 4 cite it directly.
2 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Visicoil, RadioMed (an IBA Co.): named in the summary without a submission number

## 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

## Indications for use
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarc can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.

Source page: https://510kreport.com/device/K100267
Methodology: https://510kreport.com/methodology