LEFORTE NEUROSYSTEM BONE SCREW

K091686 · Jeil Medical Corporation · HWC · Nov 13, 2009 · Orthopedic

Device Facts

• Record ID: K091686
• Device Name: LEFORTE NEUROSYSTEM BONE SCREW
• Applicant: Jeil Medical Corporation
• Product Code: HWC · Orthopedic
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• 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 Screw consists of titanium alloy (ASTM F136) bone screws, including common, self-drilling (auto), and NS auto variants. Available in micro, mini, and maxi sizes. Used by surgeons in clinical settings for fixation of mid-face and craniofacial skeleton during trauma, reconstructive, or orthognathic procedures. Device provides mechanical stabilization of bone segments to facilitate healing. Potential benefits include structural support for bone reconstruction; risks include infection, nonunion, migration, or metal sensitivity.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Material: Titanium alloy (ASTM F136). Types: Common bone screws, self-drilling (auto) screws, NS auto screws. Sizes: Micro, mini, maxi. Sterilization: Not specified (non-sterile). Connectivity: None. Software: None.

Indications for Use

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

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes (USA) Neuro Plate and Screw System (K042365)
• Synthes (USA) 1.3mm Craniofacial Screws (K021850)

Submission Summary (Full Text)

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K091686

# Medical Corporatio

Extribit 5 510(k) Summary of Safety and Effectiveness

NOV 1 8 2009

Model: LeForte Neuro System Bone Screw (Various Models)

| 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
রে, Device Information Proprietary/Trade Name: LeForte Neuro System Bone Screw Common/Usual Name: Bone Screw Classification Name: Screw, Fixation, Intraosseous Classification Product Code: DZL Device Class: Class II per regulation 21 CFR 872.4880

- 心.
【人】【 New or Modification
The application is intended for premarket notification of new medical device, LeForte Neuro System Bone Screw, for US market

- ్త. - 1.40 Tay Marketed Device
- Plate, Souc (Model: Synthes (USA) Neuro Plate and Screw System) manufactured by ・・
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Synth > (USA) - K042365, Decision Date: 11/18/2004, JEY (Class II per regulation 21CRF 372.4760)

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K091686

- 2) Screw, Fixation, Intraosseous (Model: Synthes (USA) 1.3mm Craniofacial Screws) manufactured by Synthes (USA) - K021850, Decision Date: 06/10/2002, DZL (Class II per regulation 21CFR 872.4880)
-
#### Description of the Device 6.

The LeForte Neuro system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw & NS auto screw). The common bone screws are classified to 4 classes: Micro screw, Mini screw, Mini screw, Maxi screw. And the auto screws (self-drilling screws) are divided to 3 classes; Micro auto, Mini auto screws. Additionally, the NS auto screws are divided to 2 classes. This device is manufactured and intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; selective orthognathic surgery of the maxilla and chin. Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirements 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; selective orthognathic surgery of the maxilla and chin.

8.

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

- 1) · Poor bone formulation, Osteoporosis, Osteomyelitis, inhibited revascularization, or
- infection can cause loosening, bending, cracking or fracture of the device or premature loss of .
- ﻧ fixation with the bone, leading to nonunion.
- 2) Nonision or delayed union which may lead to breakage of the implant.
- Migration, bending, fracture or loosening of the implant. 3)
- Metal sensitivity, or allergic reaction to foreign body 4)
- Decrease in bone density due to stress shielding 5)
- 6) Pain. discomfort, or abnormal sensation due to the presence of the device
- Increased fibrous tissue.response around the facture site and/or the implant 7)
- 8) Necrosis of bone
- ਰੇ) Inadequate healing

Apart from these adverse effects there are always possible complications of any surgical procedure

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such as, but not limited to, infection, nerve damage and pain which may not be related to the ...." implant. . -- --

K091686

#### Safety and Effectiveness Comparison to Predicate Devices റ്റ.

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| Device Name | Leforte Neuro System<br>Bone Screw (New) | Synthes(USA) 1.3mm<br>Craniofacial Screws<br>(K021850) | Synthes(USA) Neuro<br>Plate & Screw System<br>(K042365) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Jeil Medical Corporation | Synthes(USA) | Synthes(USA) |
| Classification | Screw, Fixation,<br>Intraosseous<br>(Class II, 21 CFR 872.<br>4880) | Screw, Fixation,<br>Intraosseous (Class II<br>21 CFR 872.4880) | Intraosseous fixation<br>screw or wire (Class II,<br>21 CFR 872. 4880)<br>Bone Plate<br>(Class II, 21 CFR 872.<br>4760)<br>Burr hole cover<br>(Class II, 21 CFR 882.<br>5250) |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Intended Use | This device is intended for<br>use in selective trauma of<br>the<br>mid-face and craniofacial<br>skeleton;<br>craniofacial surgery:<br>Reconstructive procedures;<br>selective orthognathic<br>surgery of the maxilla and<br>chin; | This device is intended for<br>use in selective trauma of<br>the mid-face and<br>craniofacial skeleton;<br>craniofacial surgery;<br>reconstructive procedures;<br>and selective orthognathic<br>surgery of the maxilla and<br>chin. | This device is intended<br>for use in selective<br>trauma of the mid-face<br>and craniofacial<br>Skeleton; craniofacial<br>surgery; reconstructive<br>procedures;<br>and<br>selective<br>orthognathic surgery of<br>the<br>maxilla and chin. |
| Single Use | Single Use | Single Use | Single Use |

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K091686

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Conclusion and in and System Bone Screws 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 is manufactured from material of titanium alloy (ASTM F136) that is used generally in this kind of bone screw. Similar devices made from titanium alloy (ASTM F136) to this device are manufactured and sold around the world. This device, LeForte Neuro system bone screw is substantially equivalent in design, material, and function to the products on the table above. These devices are certificated by notified body for CE.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 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

NOV 1 3 2009

Re: K091686

Trade/Device Name: LeForte Neuro System Bone Screw (Various Models) Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: October 19, 2009 Received: October 21, 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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#### Exhibit 4 Indications for Use

510(k) number (if known): _

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

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 _____________________________________________________________________________________________________________________________________________________________ > AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Mulin for M SR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091686