(266 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical testing of bone plates and screws, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as "Bone Plates and Screws" intended for "reconstruction procedures" and "surgery of the maxilla and chin," which are therapeutic interventions.
No
The device description indicates it is composed of bone plates and screws intended for surgical reconstruction and trauma, not for diagnosing conditions.
No
The device description explicitly details physical components made of titanium (bone plates and screws), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures involving bone fixation in the mid-face, maxilla, and chin. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as bone plates and screws made of titanium. These are physical implants used to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
The LeForte System Bone Plates are manufactured of pure Titanium (ASTM F67 Grades 1.2, and 3) and Screws of Titanium Alloy (ASTM F136), supplied non-sterile and intended for single use in selective trauma of the mid-face; reconstruction procedures; and selective orthognathic surgery of the maxilla and chin.
This 510(k) notification includes the addition of LeForte System Bone Plates (Orbital Mesh, A, Angled Locking, Pre-bending L, Curved Locking, Straight reconstruction Locking, Straight BSSO Locking, Angled Reconstruction Locking, Multi Reconstruction Locking, and Straight Locking) having thicknesses of 0.2 to 2.5mm, lengths of 5.2 to 223.5mm and heights of 4.2 to 46.8mm, and Bone Plate Screws (Mini Locking Auto Screw, Maxi Locking Auto Screw, Mini Locking Common Screw and Maxi Locking Common Screw) having head diameters of 1.2 to 2.65mm, thread diameters of 0.7 to 1.6mm and lengths of 4.0 to 18.0mm.
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)
Pre-clinical performance testing included dimensional, torsion, pull-out, four point bending and tensile strength tests for the compliance to pre-defined standards and Jeil Medical design controls.
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.
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
§ 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
ા ટનર રેન્ડ ક
Special 510(k) - LeForte System Bone Plate & Screw
MAY 1 8 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: April 23, 2012
Sponsor:
| 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 System Bone Plate & Screw .
- Common Name Bone Plate, Bone Screw
- Classification Name Plate, Bone
Screw, Fixation, Intraosseous
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
- Regulatory Classifications, Product Code: 4.
21 CFR 872.4760, JEY, Bone Plate, Class 2
21 CFR 872.4880, DZL, Screw, Fixation, Intraosseous, Class 2
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.
-
- Description:
The LeForte System Bone Plates are manufactured of pure Titanium (ASTM F67 Grades 1.2, and 3) and Screws of Titanium Alloy (ASTM F136), supplied non-sterile and
- Description:
1
Special 510(k) - LeForte System Bone Plate & Screw
intended for single use in selective trauma of the mid-face; reconstruction procedures; and selective orthognathic surgery of the maxilla and chin.
This 510(k) notification includes the addition of LeForte System Bone Plates (Orbital Mesh, A, Angled Locking, Pre-bending L, Curved Locking, Straight reconstruction Locking, Straight BSSO Locking, Angled Reconstruction Locking, Multi Reconstruction Locking, and Straight Locking) having thicknesses of 0.2 to 2.5mm, lengths of 5.2 to 223.5mm and heights of 4.2 to 46.8mm, and Bone Plate Screws (Mini Locking Auto Screw, Maxi Locking Auto Screw, Mini Locking Common Screw and Maxi Locking Common Screw) having head diameters of 1.2 to 2.65mm, thread diameters of 0.7 to 1.6mm and lengths of 4.0 to 18.0mm.
7. Indication for use:
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
-
- 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.
-
- 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.
- Predicate comparison:
The LeForte System Bone Plates & Screws have the same device characteristics, material, design and intended use as the predicate devices.
2
· ·
| Parameter | LeForte System
Bone Plate & Screw
Jeil Medical Corporation | LeForte Neuro System Bone Plate,
LeForte Neuro System Bone Screw
Jeil Medical Corporation |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) # | Modified | K091679, K103778, K091686 |
| Indications
for use | This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin. | |
| Shape | The same models as the right
plus
Orbital Mesh
A
Angled Locking
Pre-bending L
Curved Locking
Straight reconstruction Locking
Straight BSSO Locking
Angled Reconstruction Locking
Multi Reconstruction Locking
Straight Locking | L
T
Mesh
Straight
Y
H
Curved
Square
Quad
X
Calvarium
Hexagon
Double Y
RC
Z
I
Compression
Chin
Rigid Straight
BSSO
Angled Reconstruction
MG
Common Screw-Micro
Common Screw-Mid
Common Screw-Mini
Common Screw-Maxi
Auto Screw-Micro
Auto Screw-Mid
Auto Screw-Mini |
| Material | Plates - Titanium ASTM F67 Grade1, 2, 3
Screws - Titanium Alloy ASTM F136 | |
| Dimensions | Plates
Length 5.2 ~ 223.5mm
Thickness 0.22.5mm | Screws2.65mm
Outer (head) diameter 1.2
Inner diameter 0.71.6mm18.0mm |
Length 4.0
| Surface | Plate: Anodizing
Screw: N/A | |
| Sterilization | Non sterile | |
| Single use | Yes | |
| Packaging | Vial, PA+PE film sealing | |
3
11. Pre-clinical Testing:
Pre-clinical performance testing included dimensional, torsion, pull-out, four point bending and tensile strength tests for the compliance to pre-defined standards and Jeil Medical design controls.
12. 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 System Bone Plate & Screw is substantially equivalent to the predicate device as described herein.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
Mr. Paul Sumner Vice President Arkin Consulting Group 1733 Canton Lane Marietta, Georgia 30062
Re: K112457
Trade/Device Name: LeForte System Bone Plate & Screw Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: April 25, 2012 Received: April 27, 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.
5
Page 2 – Mr. Sumner
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/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,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Special 510(k) -- LeForte System Bone Plate & Screw
Indications for Use Statement
510(k) Number (if known)
Device Name
LeForte System Bone Plate & Screw
Indications for Use
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
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)
Sween Rumm
Division Sign-Off) ്വീഴിടിon Sign-On/
Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: KC1)2457
Indications For Use Statement