# K182949: Healix™ Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, LLC
- Decided: Dec 4, 2018 after 42 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 K973309 (1998). 5 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw, Vilex, Inc. (1999) Summary page 5.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999) Summary page 5.
- K973309: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Vilex, Inc. (1998) Summary page 5.

## Most influential descendants
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own
- K260291: Vortex5 Tailor's Bunion Correction System (2026), 0 descendants of its own
- K242896: Caliber Intramedullary Fixation System (2025), 0 descendants of its own
- K200914: Healix Compression Screw System (2020), 0 descendants of its own

## 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/K182949
Methodology: https://510kreport.com/methodology