# K191771: SECURE Screw

- Pathway: 510(k) (Traditional)
- Applicant: A.M. Surgical, Inc.
- Decided: Oct 16, 2019 after 106 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: 1 generation back to K050636 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 4.

## Indications for use
The SECURE Screw Fixation Device is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

Source page: https://510kreport.com/device/K191771
Methodology: https://510kreport.com/methodology