The LeForte System II is intended for use in selective trauma of mid-face, reconstruction procedure and selective orthognathic surgery of the maxilla and chin.

Device Description

The LeForte System II is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The LeForte System II is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67: Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136: Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The Self-tapping screws, Self-drilling screws & Self-tapping locking screws diameter is from 1.3 to 2.7mm and lengths is from 2mm to 20mm. It also includes various manual surgical instruments such as drill bits, driver shafts, depth gauge, bender and hand body, etc.. The LeForte System II is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the user prior to surgery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "LeForte System II," a bone plate and screw system, and includes a summary of non-clinical bench tests for showing substantial equivalence to predicate devices. However, it does not describe an AI or algorithm-based device.

Therefore, the requested information regarding acceptance criteria and studies for an AI/algorithm device (including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) cannot be extracted from this document, as it pertains to a physical medical device (bone plates and screws) rather than a software-based or AI-driven system.

The document focuses on:

Device Description: Rigid fixation system of plates and screws.
Materials: Pure Titanium and Titanium Alloy (Ti-6Al-4V) meeting ASTM standards.
Indications for Use: Selective trauma of mid-face, reconstruction procedure, and selective orthognathic surgery of the maxilla and chin.
Technological Characteristics: Comparison to predicate devices regarding design features, materials, and operating principle.
Non-Clinical Test Summary: Bench tests performed to verify design specifications and compliance with ASTM F 382-99 (Metallic Bone Plates) and ASTM F 543-07 (Metallic Medical Bone Screws).
- Tests for Plates: Dimension test, Bending strength test.
- Tests for Screws: Dimension test, Driving torque test, Axial pull-out test, Torsion test.
Substantial Equivalence: A detailed table comparing the subject device to primary and reference predicate devices across various attributes like indications for use, plate design, plate thickness, hole shape, screw type and diameter, screw length, material, surface coating, sterilization, and single use.

Since the device is a physical implant, not an AI or algorithm, the acceptance criteria and study details requested for AI performance are not relevant and thus not present in the document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

September 17, 2015

Jeil Medical Corporation c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92831

Re: K150965

Trade/Device Name: LeForte System II Regulation Number: 21 CFR 872.4760 Regulation Name: Bone plate Regulatory Class: II Product Code: JEY Dated: August 14, 2015 Received: August 19, 2015

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.

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo consists of a colorful abstract design on the left, followed by the word "JEIL" in orange, and the words "MEDICAL CORPORATION" in gray. The abstract design features a combination of green, blue, orange, and gray shapes.

702·703·704·705·706·804·805·807·812-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535

Indication for Use

510(k) Number (if known): K150965

Device Name: LeForte System II

Indication for Use:

The LeForte System II is intended for use in selective trauma of mid-face, reconstruction procedure and selective orthognathic surgery of the maxilla and chin.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use 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)

Page 1 of 1

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510(k) Summary

[As required by 21 CRF 807.92]

1. Date Prepared [21 CRF 807.92(a)(a)]

August 31, 2015

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Sponsor: Jeil Medical Corporation Address: 702-703-704-705-706-804-805-807-812-ho, 55 i Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
. Contact Name: Jieun KIM (Ms.) / RA Specialist
Telephone No. : +82 2 850 3500 -
Fax No. : +82 2 850 3525 ı
-Email Address : jekim@jeilmed.co.kr
Registration Number: 3004049923 .
Name of Manufacturer: Same as Sponsor

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

Trade Name: • LeForte System II
Common Name: Bone plates and screws •
Classification Name: Single/multiple component metallic bone fixation appliances and • accessories
Classification Panel: Dental
. Classification Regulation: 21 CFR 872.4760
Product Code: JEY ●
. Device Class: II

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

Primary Predicate Device:

• 510(k) Number:	K112457
• Applicant:	Jeil Medical Corporation
• Common Name:	Bone plates and screws
• Device Name:	LeForte System

Reference Predicate Device:

• 510(k) Number:	K080694
• Applicant:	OsteoMed L.P.

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Common Name: Bone plates and screws •
. Device Name: OsteoMed Modular Locking Fixation System

5. Description of the Device [21 CFR 807.92(a)(4)]

The LeForte System II is rigid fixation consisting of plates and screws in various configurations, shapes and sizes.

	Plate	Self-tappingScrew	Self-drillingScrew	Self-tappingLocking Screw
Type /Configuration	242.Series	241.01 Series	241.02 Series	241.03 Series
Material	ASTM F 67Pure Titanium	ASTM F 136Titanium Alloy(Ti-6Al-4V)	ASTM F 136Titanium Alloy(Ti-6Al-4V)	ASTM F 136Titanium Alloy(Ti-6Al-4V)

The LeForte System II is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67: Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136: Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The Self-tapping screws, Self-drilling screws & Self-tapping locking screws diameter is from 1.3 to 2.7mm and lengths is from 2mm to 20mm. It also includes various manual surgical instruments such as drill bits, driver shafts, depth gauge, bender and hand body, etc.. The LeForte System II is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the user prior to surgery.

6. Indications for Use [21 CFR 807.92(a)(5)]

The LeForte System II is intended for use in selective trauma of the mid-face, reconstruction procedure and selective orthognathic surgery of the maxilla and chin.

7. Technological Characteristics [21 CFR 807.92(a)(6)]

Le Forte System II. Bone Plates: Based on a technical feature comparison, the subject device was found to be similar to the predicate devices in regards to design and materials. The subject plates also have a polyxial locking feature, similar to the design used in the primary predicate device (K112457).

LeForte System II. Bone Screws: Both the subject and the predicate devices share similar head, neck and thread designs.

Non-Clinical Test Summary:

Bench tests were conducted to verify that the proposed device met all the design specifications. The test results demonstrated that the proposed device complies with the following standards:

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ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates
ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone . Screws

The following tests were performed on the subject device and the primary predicate device:

. Plates
- -Dimension test
- Bending strength test per ASTM F382 -
Screws
- Dimension test .
- Driving torque test per ASTM F543-07
- । Axial pull-out test per ASTMV F543-07
- . Torsion test per ASTM F543-07

The results of the testing support that the LeForte System II is substantially equivalent to the predicate device.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

	Subject Device	Primary PredicateDevice	ReferencePredicate Device	Similarity/DifferenceDiscussion

Device Name	LeForte System II	LeForte SystemBone Plate & Screw	OsteoMed ModularLocking FixationSystem	Different
510(k) Number	K150965	K112457	K080694	Different
Manufacturer	Jeil MedicalCorporation	Jeil MedicalCorporation	OsteoMed L.P.	Different
Indications forUse	Intended for use inSelective trauma ofthe mid-face,reconstructionprocedures andselectiveorthognathic surgeryof the maxilla andchin.	Intended for use inSelective trauma ofthe mid-face,reconstructionprocedures andselectiveorthognathic surgeryof the maxilla andchin.	Indicated for fracturefixation in cranio-maxillofacial traumareconstruction,mandibularreconstruction andorthognathicreconstruction.	Same
	Subject Device	Primary PredicateDevice	ReferencePredicate Device	Similarity/DifferenceDiscussion
Plate Design	• Non-Locking Type- Curved Type- Straight Type- Square Type- Quad Type- L Type- Double Y Type- X Type- I Type- Chin Type	• Non-Locking Type- Curved Type- Straight Type- Square Type- L Type- Double Y Type- X Type- I Type- Chin Type- Calvarium Type- Mesh Type- H Type- Hexagon Type- Quad Type- T Type- Y Type- RC Type- Z Type- Rigid StraightType- MG Type- A Type- Angled Type- AngledReconstructionType- MultiReconstructionType- ReconstructionType- BSSO Type	• Non-Locking Type- Curved Type- Straight Type- L Type- Double Y Type- X Type- I Type- Chin Type- Mesh Type- H Type- Quad(Square)Type- Y Type- Z Type- BSSO Type- Orbital Type	SimilarityThere are three sameplate type categories inthe subject device andthe predicate devices.Difference There area few additions withminorshape changes to eachcategory in the subjectdevice comparing to theprimary predicatedevice. However, thedifference in shape isvery minor; it is notintroducing significantlydifferent design, and theperformance test resultssupported that thisdifference does not raisean issue in performance.Overall, the subjectdevice plates aredesigned to enhancestrength; the width andthe cross-sectional areaare larger than theprimary predicatedevices.
	• Compression Type- Straight Type- Angled Type- Curved Type	• Compression Type- Straight Type- Angled Type	• Compression Type- Straight Type
	Subject Device	Primary PredicateDevice	ReferencePredicate Device	Similarity/DifferenceDiscussion
	• Locking Type- AJ Type- Curved Type- L Type- Square Type- Straight Type- X Type- I Type- Double Y Type- Z Type- Angled Type- AngledReconstructionType- MultiReconstructionType- ReconstructionType- BSSO Type	• Locking Type- Curved Type- Straight Type- Angled Type- ReconstructionType- AngledReconstructionType- MultiReconstructionType- BSSO Type	• Locking Type- Curved Type- Straight Type- Angled Type- Condyle Plate- ComminutionType- Strut Type- ReconstructionType
Plate Thickness	0.5mm0.6mm0.8mm1.0mm1.3mm2.5mm	0.1mm0.2mm0.3mm0.4mm0.5mm0.6mm0.8mm1.0mm1.3mm2.5mm	0.25~~2.5mm1.0mm~~2.5mm	SimilarityThe plate thicknessrange of the subjectdevice is within therange of the predicatedevices.
Hole Shape	"O" shape (circle)	"O" shape (circle)	"O" shape (circle)	Same
Screw Type andDiameter	• Self-tapping Screw1.3mm1.5mm(Emergency)1.6mm1.8mm(Emergency)2.0mm2.3mm(Emergency)2.4mm2.7mm(Emergency)	• Self-tapping Screw1.2mm1.5mm (Emergency)1.6mm1.9mm (Emergency)2.0mm2.3mm (Emergency)2.4mm2.7mm (Emergency)	• Self-tapping Screw1.2mm1.5mm1.6mm1.9mm2.0mm2.3mm2.4mm2.7mm	SimilarityThe subject devicescrews are designed toenhance strength; thecore-diameter of thescrews is larger than theprimary predicatedevices.The screw diameter and
	• Self-drilling Screw1.4mm1.6mm2.0mm	• Self-drilling Screw1.4mm1.6mm2.0mm	• Self-drilling Screw1.2mm1.6mm2.0mm	length range of thesubject device is withinthe range of the
		Subject Device	Primary PredicateDevice	ReferencePredicate Device	Similarity/DifferenceDiscussion
		• Self-tappingLocking Screw2.0mm2.4mm	• Locking Screw(Self-tappingLocking Screw)2.0mm2.3mm Emergency2.4mm2.7mm Emergency	• Locking Screw(Self-tappingLocking Screw)2.0mm2.3mm2.4mm2.7mm	predicate devices.
Screw Length		• Self-tapping Screw2 - 20mm• Self-drilling Screw3 - 12mm	• Self-tapping Screw2 - 20mm• Self-drilling Screw3 - 12mm	• Self-tapping Screw2 - 20mm• Self-drilling Screw3 - 8mm
		• Self-tappingLocking Screw3 - 20mm	• Self-tappingLocking Screw4 – 18mm	• Self-tappingLocking Screw4 – 22mm
Bone plates areused withgeneral surgicalinstrumentation		Yes	Yes	Yes	Same
Material	Plate	Titanium (ASTMF67)	Titanium (ASTMF67)	Titanium (ASTMF67)	Same
	Screw	Titanium Alloy(ASTM F136)	Titanium Alloy(ASTM F136)	Titanium Alloy(ASTM F136)	Same
Surface casting		Plate - AnodizingScrew - Anodizing	Plate - Anodizing	Plate - AnodizingScrew - Anodizing	Same
Sterilization		Non-sterile, Steamsterilization priorto use	Non-sterile,Steam sterilizationprior to use	Non-sterile,Steam sterilizationprior to use	Same
Single Use		Yes	Yes	Yes	Same

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When compared to the predicate device (K112457), the LeForte System II presented in this submission has similar;

. Intended Use
. Technological characteristics
Operating principle .
. Design features
Performance
. Biocompatibility
. Materials
. Size
. Method of sterilization and sterility assurance level

The subject device has slight differences in design from the predicate devices which are intended to enhance strength with the wider plates and the screws having larger core diameter. However, the performance test results support that this difference does not raise an issue in performance.

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OsteoMed Modular Locking Fixation System (K080694) is identified as a reference predicate device which encompasses the length range of the subject device.

9. Conclusion [21 CFR 807.92(b)(3)]

In all the respects, the LeForte System II is the substantially equivalent to currently marketed devices. This device is made of the same materials and has similar dimensions and characteristics. Based on the information provided in this submission, we conclude that the LeForte System II is substantially equivalent to the predicates in design, material, and functions.

Regulation Number and Section

§ 872.4760 Bone plate.

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