# K200914: Healix Compression Screw System

- Pathway: 510(k) (Special)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: May 5, 2020 after 29 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: 2 generations back to K973309 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182949: Healix™ Compression Screw System, Nvision Biomedical Technologies, LLC (2018) Summary page 5.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 5.
- K081149: Biopro GO-EZ Screw, Biopro, Inc. (2008) Summary page 5.

## Indications for use
The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Source page: https://510kreport.com/device/K200914
Methodology: https://510kreport.com/methodology