Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bone plate and screw system made of titanium, with no mention of software, algorithms, image processing, or AI/ML terms.

Therapeutic

No
The device, a bone plate and screw system, is used in cranial surgery and reconstructive procedures to stabilize or replace bone, which is a structural rather than a therapeutic function.

Diagnostic

No
The device description indicates it is a "Bone Plate & Screw" intended for "cranial surgery and reconstructive procedures." This describes a surgical implant used for treatment, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is made of Titanium and Titanium Alloy, indicating it is a physical hardware device (bone plate and screw).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for "selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures." This describes a surgical implant used directly on the patient's body.
Device Description: The description confirms it's a "Bone Plate & Screw" made of titanium, which are physical implants used in surgery.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on these in vitro tests.

Therefore, the LeForte Neuro System Bone Plate & Screw is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GWO, GXR, HBW

Device Description

"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 the cranial skeleton, cranial surgery and reconstructive procedures."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cranial skeleton

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K091679, K103778, K091686

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

K112812

FEB 2 2 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: January 17, 2012

1. Contact:

	Company
Name	Jeil Medical Corporation
Address	#702, Kolon Science Valley 2nd
811, Guro-dong, Guro-gu, Seoul, 152-050,
Republic of Korea
Phone	+82 2 850-3524
Fax	+82 2 850-3525
Contact	Mr. Ron Arkin
Internet	ronarkin@arkinconsulting.com

2. Device:

· Proprietary Name -	LeForte Neuro System Bone Plate & Screw
· Common Name -	Bone Plate, Bone Screw
· Classification Name -	Plate, Cranioplasty, Preformed, Alterable

Plate, Cranioplasty, Preformed, Alterable Fastener, Plate, Cranioplasty

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
1. Regulatory Classifications, Product Code: 21CFR882.5320, GWO, Class II 21CFR882.5360, HBW, Class II

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.

1. Description:
  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 the cranial skeleton, cranial surgery and reconstructive procedures.

1

LeForte Neuro System Bone Plate & Screw

1. Indications for Use:
  This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.
1. 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.
1. 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.

1. Predicate comparison:
  The LeForte Neuro System Bone Plate & Screw has the same device characteristics, material, design and intended use as the predicate devices identified.

| Parameter | LeForte Neuro System
Bone Plate & Screw
Jeil Medical Corporation | LeForte Neuro System Bone Plate,
LeForte Neuro System Bone Screw
Jeil Medical Corporation |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | Modified
v | K091679, K103778, K091686 |
| Indications
for use | This device is intended for use in selective trauma of the cranial skeleton,
cranial surgery and reconstructive procedures. | |
| Shape | The same models with the addition of
Triangular shapes | Mesh, Straight, Y, Curved, Square,
Quad, X, Calvarium, Double Y, Gap,
Bur hole, Mesh_MA, Mesh_MB,
Mesh_MC, Mesh_MD, NF Auto
Screw-Micro, NF Auto Screw-Mid |
| Dimensional | Plate thickness 0.30.6m
Screw Outer diameter 1.41.9mm
Screw Length 2.2~~5.0mm | Plate thickness 0.3~~0.6m
Screw Outer diameter 1.41.9mm
Screw Length 3.05.0mm |
| Material | Plate - Titanium ASTM F67 Grade1, 2, 3
Screw - Titanium Alloy ASTM F136 | |

2

LeForte Neuro System Bone Plate & Screw

| Parameter | LeForte Neuro System
Bone Plate & Screw
Jeil Medical Corporation | LeForte Neuro System Bone Plate,
LeForte Neuro System Bone Screw
Jeil Medical Corporation |
|---------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Surface | Plate: Anodizing
Screw: N/A | |
| Sterilization | Non sterile | |
| Single use | Yes | |
| Packaging | Vial, PA+PE film sealing | |

l 1. 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.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

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

Jeil Medical Corporation c/o Mr. Paul Sumner Official Correspondent Arkin Consulting Group LLC 1733 Canton Lane Marietta, GA 30062

Re: K112812

LeForte Neuro System Bone Plate & Screw Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: January 19, 2012 Received: January 23, 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.

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

FEB 2 2 2012

4

Page 2 - Mr. Paul Sumner

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

LeForte Neuro System Bone Plate & Screw

Indications for Use Statement

510(k) K112812 Number (if known)

Device LeForte Neuro System Bone Plate & Screw Name

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

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)

Lia Nguyen

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K 11-2812 510(k) Number_

Indications For Use Statement