OSTEOMED QUICKFIX

K962774 · Osteomed Corp. · DZL · Oct 10, 1997 · Dental

Device Facts

• Record ID: K962774
• Device Name: OSTEOMED QUICKFIX
• Applicant: Osteomed Corp.
• Product Code: DZL · Dental
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.

Device Story

Osteomed QUICK-FLIX™ is a metallic bone fixation fastener system; includes smooth or threaded fasteners, bone screws, and associated surgical instruments (drill bits, screwdrivers, wire twisters, cutters). Used by clinicians in the oral cavity to provide temporary ligature and wire lock fixation. Functions as an adjunct to primary fixation devices to stabilize fractured bone segments. Device provides mechanical constriction and stabilization during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fasteners (smooth or threaded); includes bone screws and manual surgical instrumentation (drill bits, screwdrivers, wire twisters, cutters).

Indications for Use

Indicated for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Bruce R. Horowitz
Manager, RA/QA
OsteoMed Corporation
3750 Realty Road
Dallas, Texas 75244

OCT 10 1997

Re: K962774
Trade Name: Osteomed QUICK-FLIX™
Regulatory Class: II
Product Code: DZL
Dated: July 9, 1997
Received: July 10, 1997

Dear Mr. Horowitz:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Horowitz

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 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 [phone] or [phone] or at its internet address "http://www.fda.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 Radiological Health

Enclosure

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# Osteomed "Indications for Use" Submission

510(K) Number: K962774

Device name: Osteomed QuickFix™
Smooth or threaded metallic bone fixation fastener; Intraoral ligature and wire lock. Bone screws and associated instruments (Drill bits, screwdrivers, etc.) in conjunction with ligature wire and associated instruments (wire twisters, cutters, etc.)

Indications For Use: Temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices

510(k) Number