DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING

K981881 · Doctor'S Research Group, Inc. · DZL · Dec 2, 1998 · Dental

Device Facts

• Record ID: K981881
• Device Name: DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
• Applicant: Doctor'S Research Group, Inc.
• Product Code: DZL · Dental
• Decision Date: Dec 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DRG Sherlock™ MF Self-Tapping and Self-Tapping/Self-Drilling Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.

Device Story

Sherlock™ MF Bone Screws are orthopedic fixation devices designed for craniofacial and mandibular trauma and reconstruction. Available in self-tapping and self-tapping/self-drilling configurations; manufactured from titanium alloy and cobalt-chromium (CoCrMo). Used by surgeons in clinical/OR settings to stabilize bone segments during reconstructive procedures. Device functions as mechanical fastener to provide rigid fixation of bone fragments. Benefits include restoration of skeletal integrity and support for healing in facial/mandibular regions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Titanium alloy and Cobalt-Chromium (CoCrMo). Configuration: Self-tapping and self-tapping/self-drilling bone screws. Intended for craniofacial and mandibular fixation. Mechanical fastener design.

Indications for Use

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

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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the figure.

DEC - 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K981881 DRG Sherlock™ MF Bone Screw, Cocrmo Self-Trade Name: Tapping, Ti Alloy Regulatory Class: II Product Code: DZL September 15, 1998 Dated: Received: September 15, 1998

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 legally marketed predicate 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 of the Act. The general controls provisions 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlation 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 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 regulations.

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 requlation (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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.fda.gov/cdrh/dsma/dsmamajn.html" .

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological 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): 五月号 | 828

Device Name: Sherlock™ MF Bone Screws

Indications for use:

The DRG Sherlock™ MF Self-Tapping and Self-Tapping/Self-Drilling Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.

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

Sandra L. Shire, DMD for USR
(Division Sign-Off)

n of Dental, Infection Control, d General Hospital De 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use