# K182212: Geo Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Gramercy Extremity Orthopedics, LLC
- Decided: Jan 11, 2019 after 149 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).
- (no number) Stryker Corporation Easy Clip Memory Metal Staples: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K112648: Asfora Bullet Cage, Medical Designs, LLC (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K003809: Rapid Drugs of Abuse Single and Multiple Test Panels, Rapid Diagnostics, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.

Source page: https://510kreport.com/device/K182212
Methodology: https://510kreport.com/methodology