Who is the manufacturer of SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM?

Synthes (Usa) filed the 510(k) submission for SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM (K954385).

What is the FDA product code for SYNTHES MANDIBULAR MODULAR FIXATION 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 MANDIBULAR MODULAR FIXATION SYSTEM?

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

Who can help prepare an FDA 510(k) submission like SYNTHES MANDIBULAR MODULAR FIXATION 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 MANDIBULAR MODULAR FIXATION SYSTEM

K954385 · Synthes (Usa) · JEY · Mar 8, 1996 · Dental

Device Facts

Record ID	K954385
Device Name	SYNTHES MANDIBULAR MODULAR FIXATION 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 Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in: - Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and craniofacial surgery - ENT: trauma of the nasal bones - Neurosurgery: osteosynthesis of the cranial bones.

Device Story

Mandibular Modular Fixation System; plate and screw fixation for bone stabilization. Input: surgical site anatomy. Operation: mechanical fixation via titanium plates and self-tapping screws (2.0mm, 2.4mm, 2.7mm). Output: rigid bone stabilization. Used in OR by surgeons (oral/maxillofacial, ENT, neurosurgery). Non-sterile delivery; requires moist heat sterilization by user. Benefit: provides structural support for bone healing/reconstruction.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Commercially pure titanium plates and screws. Self-tapping screw diameters: 2.0 mm, 2.4 mm, 2.7 mm. Mechanical fixation principle. Non-sterile; sterilization via moist heat.

Indications for Use

Indicated for patients requiring osteosynthesis in oral, maxillofacial, ENT (nasal bone trauma), and neurosurgical (cranial bone) procedures, including trauma, reconstructive surgery, and correction of dentofacial deformities.

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

W. Lorenz Würzburg Titanium Miniplate System

Related Devices

K043297 — MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM · Medicon EG · Feb 23, 2005
K143338 — Argulated Locking Plates · Osteomed LP · Apr 1, 2015
K113567 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM · Synthes, Inc. · Nov 19, 2012
K071612 — MODUS TRILOCK 2.0/2.3/2.5 · Medartis AG · Sep 11, 2007
K072463 — SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM · Satyrne Medical · Nov 29, 2007

Submission Summary (Full Text)

{0} SYNTHES K954385 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 September 15, 1995 Device: Synthes Mandibular Modular Fixation System, as compared to the W. Lorenz Würzburg Titanium Miniplate System. The Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in: - Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and craniofacial surgery - ENT: trauma of the nasal bones - Neurosurgery: osteosynthesis of the cranial bones. The plates are available in a variety of shapes and sizes and attach to bone via 2.0 mm, 2.4 mm, or 2.7 mm self-tapping screws. The W. Lorenz Würzburg Titanium Miniplate System, manufactured from titanium, and is intended for use in the following: - Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and craniofacial surgery - ENT: trauma of the nasal bones - Neurosurgery: osteosynthesis of the cranial bones The plates are also available in a variety of shapes to accommodate various fracture types, and attach to bone via 2.0 mm or 2.3 mm self-tapping screws. 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 Mandibular Modular Fixation System is substantially equivalent to the W. Lorenz Würzburg Titanium Miniplate System.