LEFORTE SYSTEM BONE PLATE & SCREW

K112457 · Arkin Consulting Group · JEY · May 18, 2012 · Dental

Device Facts

• Record ID: K112457
• Device Name: LEFORTE SYSTEM BONE PLATE & SCREW
• Applicant: Arkin Consulting Group
• Product Code: JEY · Dental
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.

Device Story

LeForte System Bone Plate & Screw consists of titanium plates and screws for rigid fixation in mid-face trauma, reconstruction, and orthognathic surgery. Plates are manufactured from pure titanium (ASTM F67) and screws from titanium alloy (ASTM F136). The system includes various plate geometries (e.g., orbital mesh, locking, reconstruction) and screw types (mini/maxi locking auto/common). Devices are supplied non-sterile for single-use. Surgeons implant these devices to stabilize bone segments during healing. The system provides mechanical support to bone structures, facilitating union and preventing displacement. Clinical benefits include restoration of anatomical structure and function in the mid-face and jaw. The device is used in clinical/surgical settings by qualified surgeons.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated through dimensional, torsion, pull-out, four-point bending, and tensile strength testing to ensure compliance with design controls and standards.

Technological Characteristics

Plates: Pure Titanium (ASTM F67 Grades 1, 2, 3). Screws: Titanium Alloy (ASTM F136). Plate thickness: 0.2-2.5mm; length: 5.2-223.5mm. Screw head diameter: 1.2-2.65mm; thread diameter: 0.7-1.6mm. Surface: Anodized plates. Non-sterile, single-use. Mechanical fixation via bone plates and screws.

Indications for Use

Indicated for patients requiring fixation in selective trauma of the mid-face, reconstruction procedures, and selective orthognathic surgery of the maxilla and chin. Contraindicated in cases of active/suspected infection, patients sensitized to titanium, or patients with disorders causing them to ignore rigid fixation limitations.

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

• LeForte Neuro System Bone Plate (K091679)
• LeForte Neuro System Bone Plate (K103778)
• LeForte Neuro System Bone Screw (K091686)

Submission Summary (Full Text)

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Special 510(k) - LeForte System Bone Plate & Screw

MAY 1 8 2012

## 510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92

Date: April 23, 2012

Sponsor:

1.

| | Company |
|----------|-------------------------------------------------------------------------------------------------|
| Name | Jeil Medical Corporation |
| Address | #702, Kolon Science Valley 2nd<br>811, Guro-dong, Guro-gu, Seoul, 152-050,<br>Republic of Korea |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Mr. Ron Arkin |
| Internet | [e-mail] |

#### 2. Device:

- Proprietary Name LeForte System Bone Plate & Screw .
- Common Name Bone Plate, Bone Screw
- Classification Name Plate, Bone

Screw, Fixation, Intraosseous

### 3. Predicate Devices:

- Jeil Medical Corporation/ LeForte Neuro System Bone Plate / K091679
- Jeil Medical Corporation/ LeForte Neuro System Bone Plate / K103778 +
- Jeil Medical Corporation/ LeForte Neuro System Bone Screw / K091686
- Regulatory Classifications, Product Code: 4.

21 CFR 872.4760, JEY, Bone Plate, Class 2

21 CFR 872.4880, DZL, Screw, Fixation, Intraosseous, Class 2

## 5. Performance Standards:

No applicable performance standards have been issued under section 514 or under section 513(b) of the Food, Drug and Cosmetic Act.

- 6. Description:
The LeForte System Bone Plates are manufactured of pure Titanium (ASTM F67 Grades 1.2, and 3) and Screws of Titanium Alloy (ASTM F136), supplied non-sterile and

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## Special 510(k) - LeForte System Bone Plate & Screw

intended for single use in selective trauma of the mid-face; reconstruction procedures; and selective orthognathic surgery of the maxilla and chin.

This 510(k) notification includes the addition of LeForte System Bone Plates (Orbital Mesh, A, Angled Locking, Pre-bending L, Curved Locking, Straight reconstruction Locking, Straight BSSO Locking, Angled Reconstruction Locking, Multi Reconstruction Locking, and Straight Locking) having thicknesses of 0.2 to 2.5mm, lengths of 5.2 to 223.5mm and heights of 4.2 to 46.8mm, and Bone Plate Screws (Mini Locking Auto Screw, Maxi Locking Auto Screw, Mini Locking Common Screw and Maxi Locking Common Screw) having head diameters of 1.2 to 2.65mm, thread diameters of 0.7 to 1.6mm and lengths of 4.0 to 18.0mm.

### 7. Indication for use:

This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.

- 8. Contraindications:
- · Not for use in cases of active or suspected infection or in patients previously sensitized to Titanium.
- · Not for use in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation plate and screw implants.
- 9. Potential Adverse Affects:
- Poor bone formulation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Nonunion or delayed union which may lead to breakage of the implant .
- Migration, bending, fracture or loosening of the implant .
- Metal sensitivity, or allergic reaction to foreign body "
- Decrease in bone density due to stress shielding .
- Pain, discomfort, or abnormal sensation due to the presence of the device .
- Increased fibrous tissue response around the fracture site and/or the implant
- Necrosis of bone .
- . Inadequate healing

Apart from these adverse effects there are always possible complications of any surgical procedure such as but not limited to, infection, nerve damage and pain which may not be related to the implant.

10. Predicate comparison:

The LeForte System Bone Plates & Screws have the same device characteristics, material, design and intended use as the predicate devices.

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· ·

| Parameter | LeForte System<br>Bone Plate & Screw<br>Jeil Medical Corporation | LeForte Neuro System Bone Plate,<br>LeForte Neuro System Bone Screw<br>Jeil Medical Corporation |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) # | Modified | K091679, K103778, K091686 |
| Indications<br>for use | This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin. | |
| Shape | The same models as the right<br>plus<br>Orbital Mesh<br>A<br>Angled Locking<br>Pre-bending L<br>Curved Locking<br>Straight reconstruction Locking<br>Straight BSSO Locking<br>Angled Reconstruction Locking<br>Multi Reconstruction Locking<br>Straight Locking | L<br>T<br>Mesh<br>Straight<br>Y<br>H<br>Curved<br>Square<br>Quad<br>X<br>Calvarium<br>Hexagon<br>Double Y<br>RC<br>Z<br>I<br>Compression<br>Chin<br>Rigid Straight<br>BSSO<br>Angled Reconstruction<br>MG<br>Common Screw-Micro<br>Common Screw-Mid<br>Common Screw-Mini<br>Common Screw-Maxi<br>Auto Screw-Micro<br>Auto Screw-Mid<br>Auto Screw-Mini |
| Material | Plates - Titanium ASTM F67 Grade1, 2, 3<br>Screws - Titanium Alloy ASTM F136 | |
| Dimensions | Plates<br>Length 5.2 ~ 223.5mm<br>Thickness 0.2~2.5mm | Screws<br>Outer (head) diameter 1.2~2.65mm<br>Inner diameter 0.7~1.6mm<br>Length 4.0~18.0mm |
| Surface | Plate: Anodizing<br>Screw: N/A | |
| Sterilization | Non sterile | |
| Single use | Yes | |
| Packaging | Vial, PA+PE film sealing | |

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## 11. Pre-clinical Testing:

Pre-clinical performance testing included dimensional, torsion, pull-out, four point bending and tensile strength tests for the compliance to pre-defined standards and Jeil Medical design controls.

## 12. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation Concludes that the LeForte System Bone Plate & Screw is substantially equivalent to the predicate device as described herein.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

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

MAY 1 8 2012

Mr. Paul Sumner Vice President Arkin Consulting Group 1733 Canton Lane Marietta, Georgia 30062

Re: K112457

Trade/Device Name: LeForte System Bone Plate & Screw Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: April 25, 2012 Received: April 27, 2012

Dear Mr. Sumner:

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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## Page 2 – Mr. Sumner

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Special 510(k) -- LeForte System Bone Plate & Screw

# Indications for Use Statement

510(k) Number (if known)

K112457

Device Name

LeForte System Bone Plate & Screw

Indications for Use

This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.

Prescription Use
(Per 21 CFR 801. Subpart D)

OR

Over-The-Counter Use (21CFR801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sween Rumm

Division Sign-Off) ്വീഴിടിon Sign-On/
Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: KC1)2457

Indications For Use Statement