# K102343: Emerge Medical Cannulated Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Nov 23, 2010 after 98 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 K962011 (1996). 6 ancestors in all.
220 later devices descend from it; 1 cites it directly.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001) Summary page 1.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own

## Indications for use
The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.

Source page: https://510kreport.com/device/K102343
Methodology: https://510kreport.com/methodology