The Lorenz Reconstruction System with Modular Screw is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Device Description

The Lorenz Reconstruction System with Modular Screw has been designed to include two plate thickness profiles; the low profile plates, 0.079" thick, and the high profile plates, 0.102" thick. Both plate profiles will have a threaded hole design for use with the modular screw. The threaded holes, spaced 0.295" apart, have an oval countersink to allow a standard screw greater angulation and compression, as necessary.

The modular screw is a two piece design; a detachable head and a threaded body for insertion into the bone. The detachable head has an inner and outer thread profile. The outer thread profile is for locking the screw head to the plate. The inner thread profile is for detaching and reattaching the head from the threaded body of the screw, as necessary. The detachable head can be taken off the threaded body of the screw after insertion into the bone. This allows the surgeon to correctly position the plate before a resection procedure. The screw head and reconstruction plate can then be removed for the resection procedure, leaving the body of the screw as points of reference for correct repositioning of the mandible after the procedure.

1.5 mm "add on" plates have been designed for use when the defect site includes bone fragments or pieces that require additional stabilization. The "add on" plates attach to the reconstruction plate using only the modular head or recon plug. The fixation of the "add on" plate to the bone site requires a standard 1.5 mm screw.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Lorenz Reconstruction System with Modular Screw," a medical device intended for mandibular fracture stabilization and reconstructive surgery. However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document is primarily a regulatory filing (510(k) summary and FDA clearance letter) that assesses substantial equivalence to existing devices rather than presenting the results of a detailed performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request with the provided input. There is no data in the text to populate the requested table or answer the specific questions about device performance and study methodology.

Summary

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MAY | | 1998

Attachment II

980512

Summary of Safety and Effectiveness

Device Name: Lorenz Reconstruction System with Modular Screw

Classification Name: Bone Plate and Bone Screw

Device Product Code: Bone Plate - 76JEY (21 CFR 872.4760) Bone Screw - 87HWC (21 CFR 888.3040)

Intended Use:

The Lorenz Reconstruction System with Modular Screw is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Device Description:

Sterility Information:

The plates and screws will be marketed as non-sterile, single use devices.

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Substantial Equivalence:

The Lorenz Reconstruction System with Modular Screw is believed to be substantially equivalent to Synthes Maxillofacial's Mandibular Fixation System and Leibinger's Locking Screw Mandibular Reconstruction Plating System.

Potential Risks:

The following is a listing of potential risks, which will be included in the package insert.

Nonunion or delayed union which may lead to breakage of the implant .
. Bending or fracture of the implant
Loosening of the implant .
Metal sensitivities or allergic reaction .
. Decrease in bone density due to stress shielding
Pain, discomfort, or abnormal sensations due to the presence of the device .
. Nerve damage due to surgical trauma
. Necrosis of bone

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | | 1998

Ms. Diana Preston Regulatory Specialist Walter Lorenz Surgical, Incorporated P.O. Box 18009 Jacksonville, Florida 32229-8009

K980512 Re : Lorenz Reconstruction System with Modular Trade Name: Screw Requlatory Class: II Product Code: JEY February 9, 1998 Dated: February 10, 1998 Received:

Dear Ms. Preston:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A ... ...... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Preston

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cls
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _1 of _1

510(k) Number (if known): Unknown

Device Name: Lorenz Reconstruction System with Modular Screw

Indications For Use: The Lorenz Reconstruction System with Modular Screw is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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RS1B for MSR

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 980512 510(k) Number __

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
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.(b)
Classification. Class II.