Mandible External Fixator - MR Conditional

K143285 · Synthes USA Products, LLC · MQN · May 28, 2015 · Dental

Device Facts

• Record ID: K143285
• Device Name: Mandible External Fixator - MR Conditional
• Applicant: Synthes USA Products, LLC
• Product Code: MQN · Dental
• Decision Date: May 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Device Story

External fixation system for maxillofacial fracture stabilization; components include adjustable parallel pin clamps, adjustable clamps, Schanz screws (2.5mm/4.0mm), K-wires (2.0mm/2.5mm), and rods (4.0mm titanium or carbon fiber). Device applied by surgeons in clinical settings to provide rigid fixation for bone healing. Subject device is identical to predicate hardware; modification limited to updated labeling for MR Conditional status. Performance validated via non-clinical testing for magnetically induced displacement, torque, RF heating, and image artifacts to ensure safety in MR environments.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing assessing MR compatibility, including magnetically induced displacement force, torque, RF heating, and image artifacts.

Technological Characteristics

External fixation system comprising adjustable clamps, Schanz screws, K-wires, and rods. Materials include titanium and carbon fiber. Device is MR Conditional. No electronic components or software.

Indications for Use

Indicated for patients requiring stabilization of maxillofacial fractures, including severe open mandibular fractures, 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 (K040169)
• Synthes Mandible External Fixator (K050378)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2015

Synthes USA Products, LLC Ms. Susan Lewandowski Project Leader, Regulatory Affairs - SMF 1302 Wrights Lane West Chester, PA 19380

Re: K143285

> Trade/Device Name: Mandible External Fixator - MR Conditional Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON Dated: April 28, 2015 Received: April 29, 2015

Dear Ms. Lewandowski:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K143285

Device Name Mandible External Fixator - MR Conditional

#### Indications for Use (Describe)

The 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, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### K143285

## 510(k) Summary

| Date Prepared: | April 28, 2015 |
|----------------|-----------------------------------------------------------------------------------------------------------|
| Submitter: | Synthes USA Products, LLC<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>United States of America |
| Contact: | Susan Lewandowski<br>[e-mail]<br>Telephone: [phone]<br>Facsimile: 484-356-9682 |
| Device Name: | Mandible External Fixator - MR Conditional |

#### Device Classification Information:

| Product Code | Device Name | Device Class | Regulation Number | Regulation Description |
|--------------|-----------------------------------------------------|--------------|--------------------|------------------------|
| MQN | External Mandibular<br>Fixator and/or<br>Distractor | 2 | 21 CFR<br>872.4760 | Bone Plate |

## Predicate Devices:

- Synthes Mandible External Fixator (K040169)
- . Synthes Mandible External Fixator (K050378)

#### Indications for Use:

The 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 Description:

The Mandible External Fixator consists of the following components: Adjustable Parallel Pin Clamp; Adjustable Clamp; 2.5mm/4.0mm Schanz Screws; 2.0 mm K-wires; 2.5 mm K-wires;; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The rods and Schanz screws are available in various lengths.

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## Comparison to Predicate Devices:

#### Indications

The Mandible External Fixator has the same Indications for Use as the predicate devices.

Technological Similarities and Difference of Mandible External Fixator to the Predicates

- The predicate devices are the same as the devices included within this submission: . components have not changed since their respective original clearances
- The difference between the subject devices and the predicate devices is the addition of MR Conditional scanning information to the labeling

#### Non-clinical performance data:

Non-clinical testing to support MR Conditional labeling include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.

The non-clinical performance data demonstrate that the Mandible External Fixator, when used in the MR environment using specified MR parameters and uses, is not adversely affected by magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.

#### Clinical performance data:

Clinical testing was not necessary.

## Substantial Equivalence:

The proposed devices have the same intended use as the predicate devices. The nonclinical testing included in this submission demonstrates that the Mandible External Fixator, when used in the MR environment using specified MR parameters and uses, is not adversely affected by magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts.

It is concluded that the information included in this submission supports substantial equivalence.