# K253858: GFS - Sterile Screws and Top Hat

- Pathway: 510(k) (Special)
- Applicant: T.A.G. Medical Products Corporation, Ltd.
- Decided: Aug 5, 2026 after 245 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903811 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110763: Latarjet Cortical Screw Set, T.A.G. Medical Products Corporation, Ltd. (2011) Summary page 5.
- K083096: Latarjet Cortical Screw Set, Tag Medical Products (2009) Summary page 5.

## Indications for use
The GFS Sterile Screws and Top Hat are intended to provide orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries for cortical bone in the shoulder.

Source page: https://510kreport.com/device/K253858
Methodology: https://510kreport.com/methodology