SYNTHES MANDIBLE EXTERNAL FIXATOR

K050378 · Synthes (Usa) · MQN · Mar 15, 2005 · Dental

Device Facts

• Record ID: K050378
• Device Name: SYNTHES MANDIBLE EXTERNAL FIXATOR
• Applicant: Synthes (Usa)
• Product Code: MQN · Dental
• Decision Date: Mar 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the 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, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Device Story

Synthes Mandible External Fixator is a mechanical orthopedic system used for stabilization of maxillofacial fractures. Components include adjustable parallel pin clamps, 4.0/2.5 Schanz screws, 2.0 mm K-wires, and 4.0 mm titanium rods. The device is designed for use in the MR environment. It is applied by surgeons in a clinical or surgical setting to provide rigid fixation for bone segments. The system stabilizes fractures, nonunions, or defects, facilitating healing and structural support during recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of adjustable parallel pin clamps (MR safe), 4.0/2.5 Schanz screws, 2.0 mm K-wires, and 4.0 mm titanium rods. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for patients requiring stabilization and treatment of maxillofacial fractures, including severe open mandibular fractures, highly comminuted closed fractures, nonunions, delayed unions, infection-associated fractures, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, 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.

Predicate Devices

• Synthes Mandible External Fixator (K050378)

Submission Summary (Full Text)

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3.0 510(k) Summary

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| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] | MAR 1 5 2005 |
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| Device Name: | Synthes Mandible External Fixator | |
| Classification: | Class II, 21 CFR §872.4760<br>Bone Plate | |
| Predicate Device: | Synthes Mandible External Fixator | |
| Device Description: | Synthes Mandible External Fixator consists of the following<br>components: An adjustable parallel pin clamp - MR safe; 4.0/2.5<br>Schanz Screws, 2.0 mm K-wires; and 4.0 mm Titanium Rods. The<br>components of this system are designed for use in the MR<br>environment. The rods and Schanz Screws are available in various<br>lengths. | |
| Intended Use: | Synthes Mandible External Fixator is intended to stabilize and<br>provide treatment for fractures of the maxillofacial area, including<br>severe open mandibular fractures, highly comminuted closed<br>fractures, nonunions and delayed unions (especially associated with<br>infection), fractures associated with infections, tumor resections,<br>facial deformity corrections, gunshot wounds, pan facial fractures,<br>burn maintenance, and bone grafting defects. | |
| Substantial<br>Equivalence: | Documentation is provided which demonstrates that Synthes<br>Mandible External Fixator is substantially equivalent to other<br>legally marketed Synthes devices. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

MAR 1 5 2005

Re: K050378

Trade/Device Name: Synthes Mandible External Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: February 14, 2005 Received: February 15, 2005

Dear Ms. Musgnung:

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. Musgnung

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/industry/support/index.html.

Sincerely vours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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## Indications for Use

| 510(k) Number (if known): | K050378 |
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| Device Name: | Synthes Mandible External Fixator |
| Indications: | Synthes Mandible External Fixator is intended to stabilize and<br>provide treatment for fractures of the maxillofacial area,<br>including severe open mandibular fractures, highly comminuted<br>closed fractures, nonunions and delayed unions (especially<br>associated with infection), fractures associated with infections,<br>tumor resections, facial deformity corrections, gunshot wounds,<br>pan facial fractures, burn maintenance, and bone grafting defects. |

Prescription Use _ X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quann

. , at Anacthesiology, General Hospital onon Control. Dental Devices

Number: L050875

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