SYNTHES QUICK LOCK IMF SYSTEM

K991004 · Synthes (Usa) · DYX · Jun 23, 1999 · Dental

Device Facts

• Record ID: K991004
• Device Name: SYNTHES QUICK LOCK IMF SYSTEM
• Applicant: Synthes (Usa)
• Product Code: DYX · Dental
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Quick Lock™ IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.

Device Story

The Synthes Quick Lock™ IMF System is a dental fixation device used for temporary jaw immobilization. It consists of brackets, arch bars, and associated instrumentation. The system utilizes a high-tensile strength fiber to circumferentially attach brackets to the dentition, providing attachment points for MMF wires and elastics. Arch bars and brackets provide additional support to the dental arch. The device is intended for use by clinicians in a dental or surgical setting to stabilize the jaw. By facilitating fixation, the system aids in the management of maxillofacial conditions requiring immobilization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 316L Stainless Steel, Ti-6Al-7NB, Vectran fiber, and Nylon. The system is a mechanical fixation assembly consisting of brackets and arch bars. No energy source or software components.

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

• Dimac Medical, Inc. Dimac Wires (K910090)
• W. Lorenz Traditional Wire and Arch Bars (K820944)
• Unisplint (K820944)
• Wall-Omnisplint Maxillofacial Fracture Kit

Submission Summary (Full Text)

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| JUN 23 1999 | K991004 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attachment VIII: | Summary of Safety and Effectiveness Information [510(k) Summary] |
| SUBMITTER | Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone] |
| | Contact: Sheri L. Musgnung |
| COMMON OR USUAL NAME | Lock, Wire, and Ligature, Intraoral |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 872.4700 |
| PREDICATE DEVICE: | Dimac Medical, Inc. Dimac Wires (K910090) W. Lorenz Traditional Wire and Arch Bars, Unisplint (K820944) Wall-Omnisplint Maxillofacial Fracture Kit (K number unkown) |
| DESCRIPTION: | The Synthes Quick Lock ^TM IMF System consists of brackets, arch bars and instrumentation which are used to facilitate temporary jaw immobilization. |
| | The Synthes Quick Lock ^TM Bracket is a dental bracket that provides an attachment point for MMF wires and elastics. It incorporates a high tensile strength fiber that circumdentially attaches the bracket to the dentition. The Quick Lock ^TM Arch Bar and Arch Bar Bracket provide additional support to the dental arch. |
| INTENDED USE: | Synthes Quick Lock ^TM IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation. |
| MATERIAL: | 316L Stainless Steel, Ti-6Al-7NB, Vectran fiber, and Nylon |

CONFIDENTIAL

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Ms. Sheri L. Musgnung Requlatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301

K991004 Re : Synthes Quick Lock™ IMF System Trade Name: Requlatory Class: II DYX Product Code: Dated: March 22, 1999 March 25, 1999 Received:

Dear Ms. Musgnung:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Musgnung

this response to your premarket notification Please note: Please note: 'this responde co four and might have under submission docs not arroos any canny one for devices under the sections 331 through 312 on 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 described in your stority promance of your device to a legally finding of substancial equivalence of follassification for your marketed predicate device robalesice to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpcollis and additionally 809.10 for in regulacion (ir devices), please contact the Office of Villo diagnostic devices// proade otionally, for questions on Compirance at (501) sectising of your device, please contact the promotion and adversioning 301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference fo information on your responsibilities under the Act may be Information on your with the first of Small Manufacturers Assistance obcathed from che brying [phone] or [phone] or at at its coll free namber (e://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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| <b>2.0</b> | <b>Indications for Use Statement</b> |
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| Page | 1 of 1 |
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| 510(k) Number (if known): | K991004 |
|---------------------------|--------------------------------|
| Device Name: | Synthes Quick Lock™ IMF System |

Indications For Use:

Synthes Quick Lock™ IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ___ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Suan Rumsey

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

CONFIDENTIAL