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K Number
K990637
Device Name
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
Manufacturer
SYNTHES (USA)
Date Cleared
1999-10-22

(238 days)

Product Code
NEI
Regulation Number
872.4770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Synthes (USA) Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

Device Description

The Locking Reconstruction Plate with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0 mm locking screws or standard 2.4 mm self-tapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is primarily a 510(k) submission letter and a summary of safety and effectiveness information for a medical device (Synthes (USA) Locking Reconstruction Plate with Condylar Head). It details the device's description, intended use, classification, and regulatory status, but it does not include details on performance acceptance criteria or study results to demonstrate those criteria were met.

§ 872.4770 Temporary mandibular condyle reconstruction plate.

(a)
Identification. A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.(b)
Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.