# 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

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Apr 26, 1999 after 19 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.
114 later devices descend from it; 14 cite it directly.
0 of 115 devices 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.

## Most influential descendants
- K124027: Monster Screw System (2013), 41 descendants of its own
- K101030: Modification to HBS Headless Bone Screw (2010), 40 descendants of its own
- K120493: Mini Cannulated Headed and Headless Screw Set (2012), 39 descendants of its own
- K071092: Asnis Micro Cannulated Screw (2007), 38 descendants of its own
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own

## Indications for use
The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indieations for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6AI4V, implant-quality titanium. When properly used with Vilex instrumentation, this screw achieves safe purchase and compression for cortical and cancellous bone fixation In the human body.

Source page: https://510kreport.com/device/K991197
Methodology: https://510kreport.com/methodology