LEFORTE NEURO SYSTEM BONE PLATE AND SCREW

K141452 · Jeil Medical Corporation · GWO · Jul 2, 2014 · Neurology

Device Facts

• Record ID: K141452
• Device Name: LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
• Applicant: Jeil Medical Corporation
• Product Code: GWO · Neurology
• Decision Date: Jul 2, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

Device Story

LeForte Neuro System consists of titanium bone plates and screws used for fixation in cranial surgery, trauma, and reconstructive procedures. Plates are manufactured from pure titanium (ASTM F67) and screws from titanium alloy (ASTM F136). The system is provided non-sterile and requires steam sterilization by the user prior to implantation. The device is intended for single use. Surgeons utilize these plates and screws to stabilize bone segments during cranial procedures. The system provides mechanical support to facilitate bone healing and reconstruction. Performance is verified through mechanical testing, including tensile strength for plates and torsion and pull-out testing for screws.

Clinical Evidence

Bench testing only. Mechanical testing included tensile strength for plates (meeting >150N criteria) and torsion (0.20Nm) and pull-out (20N) testing for bone screws. No clinical data provided.

Technological Characteristics

Materials: Plate (CP Ti Gr. 1, 2, 3, 4 per ASTM F67), Screw (Ti 6Al 4V ELI per ASTM F136). Surface treatment: Anodization (plates). Dimensions: Plate thickness 0.3-1.0mm; Screw diameter 1.4-1.8mm; Screw length 2.2-5.0mm. Sterilization: Non-sterile, steam sterilization by user. Mechanical properties verified via tensile, torsion, and pull-out testing.

Indications for Use

Indicated for patients requiring fixation in selective trauma of the cranial skeleton, cranial surgery, and reconstructive procedures.

Regulatory Classification

Identification

A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• LeForte Neuro System Bone Plate & Screw (K112812)

Submission Summary (Full Text)

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# 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: May 27, 2014

## 1. 510K Applicant / Submitter:

Jeil Medical Corporation 702.703.704.705.706.805.807.812-ho 55. Digital-ro 34-gil, Guro-gu, Seoul, 152-728. Republic of Korea Tel : [phone] Fax: [phone]

## 2. Submission Contact Person

LK Consulting Group USA. Inc. 2651 E Chapman Ave Ste 110, Fullerton. CA 92831 Priscilla Juhee Chung Phone: [phone] Fax: [phone] Email: juhee.c(@lkconsultinggroup.com

# 3. Device

- Proprietary Name -LeForte Neuro System Bone Plate & Screw ·
- . Common Name -Neuro Plating System
- Classification Name Preformed Alterable Cranioplasty Plate: . Burr hole cover; Cranioplasty plate fastener

#### 4. Predicate Device

LeForte Neuro System Bone Plate & Screw by Jeil Medical Corporation (K112812)

#### 5. Product Codes:

GWO, GXR. HBW

# 6. Classification Regulation:

21CFR§882.5320 21CFR§882.5250 21CFR §882.5360

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# 7. Description:

The LeForte Neuro System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The LeForte Neuro System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, convenience kits of bone plates and bone screws, and accessories to assist in the operational procedures. The LeForte Neuro System Bone Plate & Screw is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

# 8. Substantial Equivalence Discussion:

The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, raw material, and use concept and employ the same anodization and sterilization method. The differences are in shape and dimensions; however: the performance test data provided in this submission proves that this differences do not raise new issues in safety and performance.

| | Subject Device | Unmodified (Predicate) Device |
|-------------------|--------------------------------------|--------------------------------------|
| 510K Number | GXR | K112812 |
| Product Code | GWO, GRX, HBW | GWO. GRA HBW |
| Manufacturer | Jeil Medical Corporation | Jeil Medical Corporation |
| Indications for | This device is intended for use in | This device is intended for use in |
| Use | selective trauma of the cranial | sclective trauma of the cranial |
| | skeleton, cranial surgery and | skeleton, cranial surgery and |
| | reconstructive procedures. | reconstructive procedures. |
| Materials | Plate - CP Ti Gr. 1,2,3, and 4 (ASTM | Plate - CP Ti Gr. 1,2,3, and 4 (ASTM |
| | F7) | F7) |
| | Screw - Ti 6Al 4V ELI (ASTM | Screw - Ti 6Al 4V ELI (ASTM |
| | FI36) | E136) |
| Dimensions | Plate thickness 0.3mm~1.0mm | Plate thickness 0.3mm~0.6mm |
| | Screw Outer Dia. 1.4~1.8mm | Screw Outer Dia. 1.4~1.8mm |
| | Screw Length 2.2~5.0mm | Screw Length 2.2~5.0mm |
| Surface Treatment | Plate - Anodization | Plate - Anodization |
| | Screw - N/A | Screw - N/A |
| Sterilization | Non-Sterile | Non-Sterile |
| | (Steam sterilization by user using | (Steam sterilization by user) |
| | same parameters as the unmodified | |
| | device) | |
| Usage | Single Use | Single Use |
| Packaging | Polyethylene Zip Lock Pouch | Polyethylene Zip Lock Pouch |
| | Cardboard Box | Cardboard Box |

# 9. Performance Tests:

- The modified LeForte Neuro System plates were tested for tensile strength. All the test

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data met pre-set criteria (over N150).

- The modified LeForte Neuro System bone screws were tested for torsion and pull out. All the test data met pre-set criteria (0.20Nom for torsion, 20N for pull out).

# 10. 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 Neuro System Bone Plate & Screw is safe and effective and substantially equivalent to the predicate device as described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60S Silver Spring, MD 20993-0002

July 2, 2014

Jeil Medical Corporation % Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave, Ste. I I 0 Fullerton, California 92831

Re: K141452

> Trade/Device Name: Leforte neuro system bone plate and screw Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: May 27, 2014 Received: June 2, 2014

Dear Ms. Chung:

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.

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

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Page 2 - Ms. Priscilla Chung

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,

# Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director

Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on fast page.

510(k) Number (if known)

## K141452

Device Name LeForte Neuro System Bone Plate & Screw

#### Indications for Use (Describe)

This device is intended for use in selective trauma of the cranial surgery and reconstructive procedures.

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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: Felipe 2014.07.02 Aquel -S 17:29:34 -04'00'