RAPID IMF

K030605 · Zygomatics , Ltd. · DYX · Jun 27, 2003 · Dental

Device Facts

• Record ID: K030605
• Device Name: RAPID IMF
• Applicant: Zygomatics , Ltd.
• Product Code: DYX · Dental
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for: - Pre-operative fixation - Per-operative fixation - Short-term (up to 3 weeks) fixation for minimally displaced fractures - Splintage post jaw dislocation

Device Story

Rapid IMF is an adjustable, flexible plastic band designed to wrap around teeth to provide anchorage for maxillo-mandibular fixation (MMF). It functions similarly to an orthodontic band. The device is used by clinicians in a dental or surgical setting to stabilize the jaw for pre-operative, per-operative, or short-term (up to 3 weeks) post-operative fixation of minimally displaced fractures and jaw dislocations. By providing a secure attachment point, it facilitates immobilization, aiding in the healing process of jaw injuries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Adjustable, flexible plastic band; form factor similar to orthodontic bands; provides mechanical anchorage for fixation; non-powered; manual application.

Indications for Use

Indicated for patients requiring maxillo-mandibular fixation and immobilization, including pre-operative and per-operative fixation, short-term (up to 3 weeks) fixation for minimally displaced fractures, and splintage following jaw dislocation.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Ms. Carol MacDonald QA/RA Manager Zygomatics, Limited 20A Montpelier Vale London SE3 OTA, UNITED KINDOM

Re: K030605

Trade/Device Name: RAPID IMFTM Regulation Number: 21 CFR 872.4600 Regulation Name: Intraoral Ligature and Lock Wire Regulatory Class: II Product Code: DYX Dated: May 11, 2003 Received: May 16, 2003

Dear Ms. MacDonald:

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 your 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 - Ms. MacDonald

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.

Susan Runne

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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Ver/ 3 - 4/24/96

| Applicant: | ZYGOMATICS LTD |
|---------------------------|----------------|
| 510(k) Number (if known): | K030605 |
| Device Name: | RAPID IMF™ |

Indications For Use:

The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for:

- 제 Pre-operative fixation
- x Per-operative fixation
- Short-term (up to 3 weeks) fixation for minimally displaced fractures
- Splintage post jaw dislocation

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Kevin Maly for MSR
K030605

sion Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ._