# K092440: Ascension Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Nov 5, 2009 after 87 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 K893512 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw, Vilex, Inc. (1999) Summary page 1.
- 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 1.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 1.
- K893512: Depuy Cannulated Bone Screw, Depuy, Inc. (1989) Summary page 1.
- K901616: Cannulated Interference Screw System, Smith & Nephew Dyonics, Inc. (1990) Summary page 1.

## Indications for use
The Ascension Cannulated Screw System is intended for the following: Fixation of fractures in long bones Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow Arthrodesis of the foot, wrist and elbow Small and long bone osteotomies

Source page: https://510kreport.com/device/K092440
Methodology: https://510kreport.com/methodology