# K191289: Bone Screw Line Addition

- Pathway: 510(k) (Traditional)
- Applicant: Vilex IN Tennessee, Inc.
- Decided: Jul 29, 2019 after 77 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 K053136 (2006). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 4.
- K140952: Charlotte Carolina Jones Fracture System Screw, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K153154: Asnis JFX System, Stryker Trauma AG (2015) Summary page 4.

## Most influential descendants
- K202817: GEO Bone Screw System (2020), 1 descendant of its own
- K230946: Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L (2023), 0 descendants of its own

## Indications for use
The Bone Screw Line Addition is intended to be used for the following indications: • Bone fractures o Jones fractures o Acute fractures o Avulsion fractures o Repetitive stress fractures o Malleolar fractures o Talus fractures o Greater tuberosity fractures • Fixation of malunions and non-unions • Osteotomies • Arthrodesis

Source page: https://510kreport.com/device/K191289
Methodology: https://510kreport.com/methodology