LEFORTE SYSTEM BONE PLATE

K091679 · Jeil Medical Corporation · JEY · Oct 2, 2009 · Dental

Device Facts

• Record ID: K091679
• Device Name: LEFORTE SYSTEM BONE PLATE
• Applicant: Jeil Medical Corporation
• Product Code: JEY · Dental
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Traditional
• 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 and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Story

LeForte Neuro System Bone Plate is a titanium implant used for internal fixation in craniofacial and mid-face trauma, reconstructive surgery, and orthognathic procedures. The device is a bone plate designed to stabilize bone segments during healing. It is intended for use by surgeons in clinical or hospital settings. The device provides mechanical support to the skeletal structure, facilitating bone union. It is supplied non-sterile and is intended for single use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Constructed from unalloyed titanium (ASTM F67). The device is a bone plate for internal fixation. It is provided non-sterile and is intended for single use. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation in selective trauma of the mid-face and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

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 (USA) Neuro Plate and Screw System (K042365)

Submission Summary (Full Text)

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K091679

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OCT - 2 2009

1 5

Exhibit 5 510(k) Summary of Safety and Effectiveness

### Model: LeForte Neuro System Bone Plate

l.

| Submitter and US Official Correspondent | |
|-----------------------------------------|--------------------------------|
| Submitter: | Jeil Medical Corporation |
| Address: | #702, Kolon Science Valley 2nd |
| | 811, Guro-dong, Guro-gu |
| | Seoul, 152-050, Korea |
| Official Correspondent: | Shin Kuk Yoo, Consultant |
| Telephone No.: | 714-313-7442 |
| Fax No.: | 801-303-7455 |
| Email: | [e-mail] |

- 2. Establishment Registration Number 3004049923
### 3. Device Information

| Proprietary/Trade Name: | LeForte Neuro System Bone Plate |
|------------------------------|-----------------------------------------|
| Common/Usual Name: | Bone Plate |
| Classification Name: | Plate, Bone |
| Classification Product Code: | JEY |
| Device Class: | Class II per regulation 21 CFR 872.4760 |

#### 4. New or Modification

The application is intended for premarket notification of new medical device, LeForte Neuro System Bone Plate, for US market.

#### ડ. Equivalent Legally Marketed Deyice

- 1) Plate, Bone (Model: Synthes (USA) Neuro Plate and Screw System) manufactured by Synthes (USA) - K042365, Decision Date: 11/18/2004, JEY (Class II per regulation 21CRF 872.4760)

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Ko91679

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### Description of the Device

6.

LeForte Neuro System Bone Plate is made of unalloyed titanium (ASTM F67) and is manufactured and intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD(93/42/EEC) and ISO 14630:1997 from the device design to manufacturing and QC.

#### 7. Indications for Use (Intended Use)

This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

#### 8. Potential Adverse Affects and Complications (Common to all devices of this type)

- l) 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. 2)
- 3) Migration, bending, fracture or loosening of the implant.
- 4) Metal sensitivity, or allergic reaction to foreign body
- 5) Decrease in bone density due to stress shielding
- 6) Pain, discomfort, or abnormal sensation due to the presence of the device
- 7) Increased fibrous tissue response around the facture site and/or the implant
- 8) Necrosis of bone
- 9) 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.

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K09 1679

| Safety and Effectiveness, comparison to Predicate device | | |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | LeForte Neuro System Bone Plate | Synthes(USA) Neuro Plate & Screw System |
| Applicant | Jeil Medical Corporation | Synthes(USA) |
| 510(k)<br>Number | New | K042365 |
| Classification | Plate, Bone<br>(Class II, 21 CFR 872. 4760) | Bone Plate<br>(Class II, 21 CFR 872. 4760)<br>Burr hole cover<br>(Class II, 21 CFR 882. 5250)<br>Intraosseous fixation screw or wire<br>(Class II, 21 CFR 872. 4880) |
| Material | Titanium | Titanium<br>Titanium Alloy |
| Intended Use | This device is intended for use in selective<br>trauma of the mid-face and craniofacial<br>skeleton; craniofacial surgery;<br>reconstructive procedures; and selective<br>orthognathic surgery of the maxilla and<br>chin. | This device is intended for use in selective<br>trauma of the mid-face and craniofacial<br>Skeleton; craniofacial surgery;<br>reconstructive procedures; and selective<br>orthognathic surgery of the maxilla and<br>chin. |
| Single use | Single Use | Single Use |
| Sterile | Non-sterile | Non-sterile |

### 10. Conclusion

In all respects, the LeForte Neuro System Bone Plates are the equivalent of currently marketed devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of the predicate device.

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

Jeil Medical Corporation C/O Mr. Shin Kuk Yoo Manager LSK BioPartners, Incoporated 215 South State Street, Suite 100B Salt Lake City, Utah 84111

OCT - 2 2009

Re: K091679

Trade/Device Name: LeForte Neuro System Bone Plate (Various Models) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 8, 2009 Received: September 10, 2009

Dear Mr. Yoo:

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 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. Yoo

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division 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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K091679

### Exhibit 4 Indications for Use

510(k) number (if known): _

Device Name: LeForte Neuro System Bone Plate (Various Models)

AND/OR

Indications for Use:

This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ > (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 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)

Kein Mulvey Son M SR

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

510(k) Number: