SAFETY RELEASE ARCH BAR KIT

K031207 · Casey Surgical, LLC · DYX · Jul 15, 2003 · Dental

Device Facts

• Record ID: K031207
• Device Name: SAFETY RELEASE ARCH BAR KIT
• Applicant: Casey Surgical, LLC
• Product Code: DYX · Dental
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Casey Surgical Safety Release TM Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.

Device Story

The Casey Surgical Safety Release Arch Bar Kit is an intraoral ligature and wire lock system used for temporary jaw immobilization. The device consists of four components installed by an oral surgeon or dentist in conjunction with ligature wires. It features a unique safety release mechanism designed to facilitate rapid removal or adjustment. The device is used in a clinical setting to stabilize the jaw; it assists the clinician in managing maxillo-mandibular fixation, potentially improving patient safety through the integrated release feature.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral ligature and wire lock system; mechanical assembly; includes a safety release mechanism. Materials and form factor are consistent with traditional arch bar systems.

Indications for Use

Indicated for intermaxillary and maxillo-mandibular fixation in patients requiring temporary jaw immobilization.

Regulatory Classification

Identification

An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.

Predicate Devices

• Synthes Quick Lock ™ (K991004)
• Unisplint (K820944)

Submission Summary (Full Text)

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K031207

# VII. 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.

### Submitter Information:

Casey Surgical, LLC 17722 Loop Road Holt, MO 64048

Contact Person: Kevin Casey

Phone: [phone]

Date Prepared: April 14, 2003

### Device Information:

Proprietary Name: Safety Release TM Arch Bar Kit

Common Name: Intermaxillary Fixation System

Classification Name: Intraoral ligature and wire lock

#### Predicate Devices: Synthes Quick Lock ™ K991004 Unisplint K820944

Device Description: The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.

Intended Use: Casey Surgical Safety Release TM Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.

Comparison of Technical Characteristics to Predicate Device: Similar to predicate devices K991004 Synthes Quick Lock™ IMF system and K8200944 Dental Arch Bar in materials of construction and indications for use. The Casey Surgical Safety Release ™ Arch Bar Kit has the additional safety release feature.

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Image /page/1/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 an eagle with three human profiles incorporated into its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 2003

Casey Surgical. LLC C/O Mr. James Stanley Associate Director of Compliance & Medical Devices Regulatory Clinical Consultants, Incorporated 200 NE Mulberry, Suite 200 Lee's Summit, Missouri 64086

Re: K031207

Trade/Device Name: Casey Surgical Safety Release™ Arch Bar Kit Regulation Number: 21 CFR 872.4600 Regulation Name: Intraoral Ligature and Wire Lock Regulatory Class: II Product Code: DYX Dated: April 14, 2003 Received: April 23, 2003

Dear Mr. Stanley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Stanley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Suser Runre

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K031207

Page 3 of 40

## I. Indications for Use

510(k) Number (if known): K031207

Device Name: Casey Surgical Safety Release TM Arch Bar Kit

Indications for Use: Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulkey for MSR

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K 031207