SYNTHES (USA) MIDFACIAL SYSTEM

K953806 · Synthes (Usa) · JEY · Mar 8, 1996 · Dental

Device Facts

• Record ID: K953806
• Device Name: SYNTHES (USA) MIDFACIAL SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Mar 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Story

Plate and screw system for midfacial/craniofacial fixation; manufactured from commercially pure (CP) titanium; includes various plate configurations and 1.3 mm or 1.7 mm self-tapping screws; low-profile design. Used in clinical settings for trauma, reconstruction, and orthognathic surgery. Provided non-sterile; requires moist heat sterilization by user. Surgeon attaches plates to bone to stabilize fractures or reconstructive sites. Benefits include structural stabilization of bone segments.

Clinical Evidence

Bench testing only. Mechanical test results confirm equivalence to predicate system.

Technological Characteristics

Commercially pure (CP) titanium plates and screws; 1.3 mm and 1.7 mm self-tapping screw diameters; low-profile design; non-sterile; requires moist heat sterilization.

Indications for Use

Indicated for patients requiring fixation in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Howmedica Luhr Pan Fixation System

Submission Summary (Full Text)

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SYNTHES
K953806

Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]

SYNTHES (USA)
1690 Russell Road
Paoli, PA 19301

[phone]
Contact: Angela Silvestri
August 9, 1995

Device: Synthes Midfacial System, as compared to the Howmedica Luhr Pan Fixation System.

The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.7 mm self-tapping screws, with a low plate/screw profile.

The Howmedica Luhr Pan Fixation System, manufactured from Vitallium® alloy, is also intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are also available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.5 mm self-tapping screws, with a low plate/screw profile.

Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended.

Based on mechanical test results, the Synthes Midfacial System is equivalent to the Howmedica Luhr Pan Fixation System.