Synthes Carniofacial Plate and Screw System

• • Terminated Z-2739-2020 FDA Class II ·initiated 16 Jun 2020

  One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).

510(k) Number

K050608 ↗

FDA Product Code

JEY

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What is the Synthes Craniofacial Plate and Screw System used for?

  This system is designed for craniofacial and midface skeletal reconstruction, stabilizing fractures, defects, or deformities in the craniofacial region, including orbital and maxillofacial structures. Its anatomically shaped plates and self-tapping screws provide rigid internal fixation to promote proper bone alignment and healing during surgical interventions.

• Is the Synthes Craniofacial Plate and Screw System sterile and single-use?

  Yes, the system is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintains the integrity of the components for a single surgical procedure, adhering to strict sterile medical device protocols.

• How are the plates and screws sized or referenced?

  The system includes a variety of plate sizes and screw lengths, each referenced by FEI numbers (e.g., 3002807305, 1000307073). These references correspond to specific anatomical requirements, allowing surgeons to select the appropriate components for their patient’s unique craniofacial structure.

• What storage and handling precautions must be followed?

  The device must be stored and handled according to sterile medical device protocols to preserve its integrity before surgical use. This includes maintaining proper packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.

• Is this system approved for dental applications?

  Yes, the Synthes Craniofacial Plate and Screw System holds FDA 510(k) clearance for dental applications, specifically for craniofacial and midface trauma reconstruction. It is classified as a Class II medical device under FDA regulations.