# K012817: Helical Compression Anchor System, Non-Cannulated

- Pathway: 510(k) (Traditional)
- Applicant: Triage Medical, Inc.
- Decided: Nov 20, 2001 after 90 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is used in general management of fractures and reconstructive surgery.

Source page: https://510kreport.com/device/K012817
Methodology: https://510kreport.com/methodology