← Product Code [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) · K954385

# SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM (K954385)

_Synthes (Usa) · JEY · Mar 8, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K954385

## Device Facts

- **Applicant:** Synthes (Usa)
- **Product Code:** [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY.md)
- **Decision Date:** Mar 8, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4760
- **Device Class:** Class 2
- **Review Panel:** Dental
- **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.

## Regulatory 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

## Submission Summary (Full Text)

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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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K954385](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K954385)

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