SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR

K971987 · Synthes (Usa) · JEY · Jun 24, 1997 · Dental

Device Facts

• Record ID: K971987
• Device Name: SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Mini External Fixator stabilizes and provides treatment for fractures of maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, burn maintenance, and bone-grafting defects.

Device Story

Synthes Mini External Fixator is a mechanical orthopedic device used for stabilization of maxillofacial fractures and bone defects. It provides external skeletal fixation to maintain bone alignment during healing. The device is applied by surgeons in a clinical or hospital setting. It functions by mechanically securing bone segments to facilitate stabilization in complex cases such as comminuted fractures, nonunions, or post-tumor resection. The output is the physical stabilization of the bone structure, which aids in proper healing and deformity correction. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical external fixation device for maxillofacial applications. Materials and specific technical dimensions are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring stabilization of maxillofacial fractures, including severe open mandibular fractures, highly comminuted closed fractures, nonunions, delayed unions, fractures with infection, tumor resections, facial deformity corrections, burn maintenance, and bone-grafting defects.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head with three stripes extending from the back of the head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sheri L. Musqnunq 'Requlatory Affairs Associate Synthes (USA) ------------1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

JUN 24 1997

Re : K971987 Trade Name: Synthes (USA) Mini External Fixator Requlatory Class: II Product Code: JEY Dated: May 28, 1997 Received: May 29, 1997

Dear Ms. Musqnung:

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 reqistration, 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. ಗ 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

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Page 2 - Ms. Musqnunq

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 leqally . . 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 at [phone].

Sincerely yours,

Patricio Cucurella

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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Image /page/2/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with an R in it is to the right of the word.

SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone [phone]

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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Synthes Mini External Fixator stabilizes and provides treatment for fractures of maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, burn maintenance, and bone-grafting defects.

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

*Susan Ruares* Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | |
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| Prescription Use | <div style="display:inline-block;">(Per 21 CFR 801.109) <span style="text-decoration:underline;">✓</span></div> |
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OR

| Over-The-Counter Use | <span style="text-decoration:underline;"></span> |
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