(160 days)
No
The device description focuses on rigid fixation hardware (plates and screws) and manual surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device, a rigid fixation system with plates and screws, is used in surgical procedures like mid-face trauma reconstruction and orthognathic surgery to mechanically support and stabilize bone structures. This fits the definition of a therapeutic device as it directly treats or alleviates a condition through physical intervention.
No
The device is described as rigid fixation consisting of plates and screws used for reconstruction procedures and orthognathic surgery, which are therapeutic interventions rather than diagnostic processes.
No
The device description explicitly states it is comprised of physical components like plates, screws, and surgical instruments made of titanium, which are hardware.
Based on the provided information, the LeForte System II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for surgical procedures involving the mid-face, maxilla, and chin. This is a surgical implant and fixation system used in vivo (within the body) during surgery.
- Device Description: The description details plates, screws, and surgical instruments made of titanium. These are physical devices used to fix bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. The LeForte System II is a surgical implant used to physically stabilize bone structures.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The LeForte System II is rigid fixation consisting of plates and screws in various configurations, shapes and sizes.
Type / Configuration:
Plates: 242.Series
Self-tapping Screw: 241.01 Series
Self-drilling Screw: 241.02 Series
Self-tapping Locking Screw: 241.03 Series
Material:
Plates: ASTM F 67 Pure Titanium
Screws: ASTM F 136 Titanium 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 10-6 by the user prior to surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mid-face, maxilla and chin
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)
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:
- 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.
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.
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.
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
§ 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.
0
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.
1
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
2
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
3
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. |
4
- 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-tapping
Screw | Self-drilling
Screw | Self-tapping
Locking Screw |
|-------------------------|----------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|
| Type /
Configuration | 242.Series | 241.01 Series | 241.02 Series | 241.03 Series |
| Material | ASTM F 67
Pure Titanium | ASTM F 136
Titanium Alloy
(Ti-6Al-4V) | ASTM F 136
Titanium Alloy
(Ti-6Al-4V) | ASTM F 136
Titanium 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:
5
- 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 Predicate
Device | Reference
Predicate Device | Similarity/Difference
Discussion | |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | | | | | |
| Device Name | LeForte System II | LeForte System
Bone Plate & Screw | OsteoMed Modular
Locking Fixation
System | Different | |
| 510(k) Number | K150965 | K112457 | K080694 | Different | |
| Manufacturer | Jeil Medical
Corporation | Jeil Medical
Corporation | OsteoMed L.P. | Different | |
| Indications for
Use | Intended for use in
Selective trauma of
the mid-face,
reconstruction
procedures and
selective
orthognathic surgery
of the maxilla and
chin. | Intended for use in
Selective trauma of
the mid-face,
reconstruction
procedures and
selective
orthognathic surgery
of the maxilla and
chin. | Indicated for fracture
fixation in cranio-
maxillofacial trauma
reconstruction,
mandibular
reconstruction and
orthognathic
reconstruction. | Same | |
| | Subject Device | Primary Predicate
Device | Reference
Predicate Device | Similarity/Difference
Discussion | |
| 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 Straight
Type - MG Type
- A Type
- Angled Type
- Angled
Reconstruction
Type - Multi
Reconstruction
Type - Reconstruction
Type - 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 | Similarity
There are three same
plate type categories in
the subject device and
the predicate devices.
Difference There are
a few additions with
minor
shape changes to each
category in the subject
device comparing to the
primary predicate
device. However, the
difference in shape is
very minor; it is not
introducing significantly
different design, and the
performance test results
supported that this
difference does not raise
an issue in performance.
Overall, the subject
device plates are
designed to enhance
strength; the width and
the cross-sectional area
are larger than the
primary predicate
devices. | |
| | • Compression Type - Straight Type
- Angled Type
- Curved Type | • Compression Type
- Straight Type
- Angled Type | • Compression Type
- Straight Type | | |
| | Subject Device | Primary Predicate
Device | Reference
Predicate Device | Similarity/Difference
Discussion | |
| | • Locking Type - AJ Type
- Curved Type
- L Type
- Square Type
- Straight Type
- X Type
- I Type
- Double Y Type
- Z Type
- Angled Type
- Angled
Reconstruction
Type - Multi
Reconstruction
Type - Reconstruction
Type - BSSO Type | • Locking Type
- Curved Type
- Straight Type
- Angled Type
- Reconstruction
Type - Angled
Reconstruction
Type - Multi
Reconstruction
Type - BSSO Type | • Locking Type
- Curved Type
- Straight Type
- Angled Type
- Condyle Plate
- Comminution
Type - Strut Type
- Reconstruction
Type | | |
| Plate Thickness | 0.5mm
0.6mm
0.8mm
1.0mm
1.3mm
2.5mm | 0.1mm
0.2mm
0.3mm
0.4mm
0.5mm
0.6mm
0.8mm
1.0mm
1.3mm
2.5mm | 0.252.5mm2.5mm | Similarity
1.0mm
The plate thickness
range of the subject
device is within the
range of the predicate
devices. | |
| Hole Shape | "O" shape (circle) | "O" shape (circle) | "O" shape (circle) | Same | |
| Screw Type and
Diameter | • Self-tapping Screw
1.3mm
1.5mm(Emergency)
1.6mm
1.8mm(Emergency)
2.0mm
2.3mm(Emergency)
2.4mm
2.7mm(Emergency) | • Self-tapping Screw
1.2mm
1.5mm (Emergency)
1.6mm
1.9mm (Emergency)
2.0mm
2.3mm (Emergency)
2.4mm
2.7mm (Emergency) | • Self-tapping Screw
1.2mm
1.5mm
1.6mm
1.9mm
2.0mm
2.3mm
2.4mm
2.7mm | Similarity
The subject device
screws are designed to
enhance strength; the
core-diameter of the
screws is larger than the
primary predicate
devices.
The screw diameter and | |
| | • Self-drilling Screw
1.4mm
1.6mm
2.0mm | • Self-drilling Screw
1.4mm
1.6mm
2.0mm | • Self-drilling Screw
1.2mm
1.6mm
2.0mm | length range of the
subject device is within
the range of the | |
| | | Subject Device | Primary Predicate
Device | Reference
Predicate Device | Similarity/Difference
Discussion |
| | | • Self-tapping
Locking Screw
2.0mm
2.4mm | • Locking Screw
(Self-tapping
Locking Screw)
2.0mm
2.3mm Emergency
2.4mm
2.7mm Emergency | • Locking Screw
(Self-tapping
Locking Screw)
2.0mm
2.3mm
2.4mm
2.7mm | predicate devices. |
| Screw Length | | • Self-tapping Screw
2 - 20mm
• Self-drilling Screw
3 - 12mm | • Self-tapping Screw
2 - 20mm
• Self-drilling Screw
3 - 12mm | • Self-tapping Screw
2 - 20mm
• Self-drilling Screw
3 - 8mm | |
| | | • Self-tapping
Locking Screw
3 - 20mm | • Self-tapping
Locking Screw
4 – 18mm | • Self-tapping
Locking Screw
4 – 22mm | |
| Bone plates are
used with
general surgical
instrumentation | | Yes | Yes | Yes | Same |
| Material | Plate | Titanium (ASTM
F67) | Titanium (ASTM
F67) | Titanium (ASTM
F67) | Same |
| | Screw | Titanium Alloy
(ASTM F136) | Titanium Alloy
(ASTM F136) | Titanium Alloy
(ASTM F136) | Same |
| Surface casting | | Plate - Anodizing
Screw - Anodizing | Plate - Anodizing | Plate - Anodizing
Screw - Anodizing | Same |
| Sterilization | | Non-sterile, Steam
sterilization prior
to use | Non-sterile,
Steam sterilization
prior to use | Non-sterile,
Steam sterilization
prior to use | Same |
| Single Use | | Yes | Yes | Yes | Same |
6
7
8
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.
9
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.