DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM

K974817 · Doctor'S Research Group, Inc. · DZL · Mar 13, 1998 · Dental

Device Facts

• Record ID: K974817
• Device Name: DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
• Applicant: Doctor'S Research Group, Inc.
• Product Code: DZL · Dental
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DRG MF Ti Alloy Bone screws are intended for craniofacial and mandibular trauma and reconstruction.

Device Story

DRG MF Titanium (Ti) Alloy Bone Screws are orthopedic fixation devices used in craniofacial and mandibular trauma and reconstruction. The screws are manufactured from titanium alloy and are available in various diameters (1.0mm to 2.4mm). They are intended for use by surgeons in clinical settings to provide rigid fixation of bone segments. The device functions by mechanically securing bone fragments to facilitate healing and structural stability. The healthcare provider selects the appropriate screw size based on the anatomical site and clinical requirements. The device benefits patients by stabilizing fractures or reconstruction sites, promoting proper bone alignment and healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium (Ti) alloy bone screws; available in diameters of 1.0mm, 1.2mm, 1.3mm, 1.5mm, 2.0mm, and 2.4mm. Mechanical fixation device.

Indications for Use

Indicated for patients requiring craniofacial and mandibular trauma repair or reconstruction. Prescription use only.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with three parallel lines representing the branches of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

Richard Deslauriers, M.D. President Doctor's Research Group, Incorporated 143 Wolcott Road Wolcott, Connecticut 06716

Re : K974817 DRG MF Titanium (Ti) Alloy Bone Screws Trade Name: 1.0mm, 1.2mm, 1.3mm, 1.5mm, 2.0mm, 2.0mm and 2.4mm II Requlatory Class: Product Code: DZL December 12, 1997 Dated: Received: December 23, 1997

Dear Dr. Deslauriers:

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, Drug, 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, labeling, and prohibitions against 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 regulations 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{1}------------------------------------------------

## Page 2 - Dr. Deslauriers

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note one 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 [phone] or [phone] or at its internet address "http://www.fdp.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{2}------------------------------------------------

## Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 [phone]

## Statement of indications for use:

510(k) Number (if Known): _ K 974817

Device Name: DRG MF Titanium (Ti) Alloy Bone Screws

Indications for use:

The DRG MF Ti Alloy Bone screws are intended for craniofacial and mandibular trauma and reconstruction.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON NOTHER PAGE IF NEEDED) Concurrence of CDRG, Office of Device Evaluation (ODE)

Susan Rumer

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

Prescription Use ~ (Per 21 CFR 801.109)

OR

Over-The-Counter Use