Who is the manufacturer of SYNTHES (USA) MIDFACIAL SYSTEM?

Synthes (Usa) filed the 510(k) submission for SYNTHES (USA) MIDFACIAL SYSTEM (K953806).

What is the FDA product code for SYNTHES (USA) MIDFACIAL SYSTEM?

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for SYNTHES (USA) MIDFACIAL SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SYNTHES (USA) MIDFACIAL SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Related Devices

K182758 — MCI - CMF System · Mci Medical Concept Innovation, Inc. · Dec 5, 2019
K112457 — LEFORTE SYSTEM BONE PLATE & SCREW · Arkin Consulting Group · May 18, 2012
K102641 — MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE · Neoortho Produtos Ortopedicos S/A · Dec 20, 2010
K033121 — 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES · Synthes (Usa) · Oct 20, 2003
K121589 — BIOMET MICROFIXATION FACIAL PLATING SYSTEM · Biomet Microfixation · Sep 21, 2012

Submission Summary (Full Text)

{0} SYNTHES K953806 Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary] SYNTHES (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 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.