FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)

K081067 · Biomet Microfixation, Inc. · JEY · May 9, 2008 · Dental

Device Facts

• Record ID: K081067
• Device Name: FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
• Applicant: Biomet Microfixation, Inc.
• Product Code: JEY · Dental
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titanium Fracture / Reconstructive Devices (TraumaOne) are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Device Story

TraumaOne system consists of titanium plates and screws for internal fixation of mandibular fractures and reconstruction. Plates feature threaded through-holes for locking screws; available in straight, angle, double angle, and crescent configurations. Used by surgeons in clinical/surgical settings for bone stabilization. Device provides mechanical support to bone segments; requires graft support for mandibular resection cases to prevent mechanical failure. Benefits include stabilization of fractures and support for reconstructive procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium alloy plates and screws; locking head screw design; threaded through-holes; non-sterile; single-use; mechanical fixation.

Indications for Use

Indicated for stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures. Contraindicated in patients with active infection, foreign body sensitivity, limited blood supply, insufficient bone quantity, latent infection, or mental/neurologic conditions preventing postoperative care. Mandibular reconstructive devices must be supported by a graft.

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

• Lorenz Titanium Fracture / Reconstructive Devices (K001238)
• Lorenz Reconstruction System (K980512)

Submission Summary (Full Text)

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K081067

Image /page/0/Picture/1 description: The image shows the logo for Microfixation, Inc. The logo consists of the word "COMET" in a stylized font with horizontal lines running through the letters. Below the word "COMET" is the text "MICROFIXATION, INC." in a smaller, simpler font.

**MAY - 9 2008**

510(k) Summary Contact: Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218-2480 Kim Reed. Regulatory Affairs Manager 904-741-9443 fax [phone]

Classification Name Plate, Fixation, Bone Bone Plate Common or Usual Name: Device Product Code: 76 JEY (21 CFR 872.4760) Device Classification: Class II

#### Reconstruction / Fracture Plating System (TraumaOne) Device Name:

The Titanium Fracture / Reconstructive Devices (TraumaOne) are intended for use in the Intended Use: stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

#### Contraindications:

- Active infection. 1.
- Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to 2. implantation.
- Patients with limited blood supply, insufficient quantity of bone, or latent infection. 3.
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative 4. care instructions.
- If used in mandibular resection cases, the mandibular reconstructive devices must be supported using a 5. graft. If mandibular reconstructive devices are not supported by a graft, the devices can be expected to fracture, bend, break or fail.

Description: The Mandibular Fracture / Reconstructive Devices (TraumaOne) are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for internal fixation of mandibular fractures and reconstruction procedures. The screws have locking head features. The plates have threaded through holes (which allows them to work with either the locking screws) and will include straight, angle, double angle, and crescent options with various lengths and thickness.

Sterility Information: The plates and screws will be marketed as non-sterile, single use devices.

### Possible risks:

- Poor bone formation, Osteolysis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can 1. cause loosening, bending, cracking or fracture of the device.
- Nonunion or delayed union, which may lead to breakage of the implant. 2.
- Migration, bending, fracture or loosening of the implant. 3.
- Metal sensitivity, or allergic reaction to a foreign body. 4.
- Decrease in bone density due to stress shielding. 5.
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
- Increased fibrous tissue response around the fracture site and/or the implant. 7.
- Necrosis of bone. 8.
- Inadequate healing. 9.
- Mandibular devices can fracture, bend, break or fail if used to bridge a mandibular resection site, in the 10. absence of a graft.

Substantial Equivalence Biomet Microfixation considers the Fracture / Reconstructive Devices (TraumaOne) equivalent to the Lorenz Titanium Fracture / Reconstructive Devices cleared under K001238 and Lorenz Reconstruction System cleared under K980512.

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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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY - 9 2008

Ms. Kim Reed Regulatory Affairs Manager Biomet Microfixation 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K081067

Trade/Device Name: Mandibular Fracture/ Reconstruction Devices (TraumaOne) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 14, 2008 Received: April 15, 2008

Dear Ms. Reed:

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. Reed

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.

Sonette H. Mckee Omd.

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

K081067 510(k) Number (if known):

Device Name: Mandibular Fracture / Reconstruction Devices (TraumaOne)

Indications For Use:

Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kain Mally Sa MSA

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

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510(k) Number: K081067