(378 days)
Not Found
No
The device description and performance studies focus on the mechanical and biological properties of the plates and screws, with no mention of AI or ML.
Yes
The device is used for procedures like treating fractures, osteotomies, reconstructive procedures, and revision procedures in maxillofacial and mandible surgery, which are therapeutic interventions.
No
The device description indicates that the Optimus CMF System consists of implantable bone screws and plates used for surgical procedures like fractures, osteotomies, and reconstructive procedures. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it comprises plates and screws made of titanium alloys, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Optimus CMF System consists of implantable bone plates and screws. These are physical devices designed to be surgically placed inside the body to stabilize bones.
- Intended Use: The intended use is for surgical procedures on the maxillofacial and mandible areas, such as fixing fractures and performing osteotomies. This is a direct surgical intervention, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
Optimus CMF System is implantable bone screws for maxillofacial and mandible surgery procedures including: 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
The OPTIMUS CMF SYSTEM comprises plates and screws. The plate thickness sizes range from 0.4 to 2.6mm. They are made of unalloyed Titanium (ASTM F67) and anodized in four colors (silver, blue, green, and gold). The diameters of the screws range from 1.3 to 2.7mm, while lengths range from 3.0 to 20.0mm. They are made of Ti-6A1-4V ELI titanium alloy (ASTM F136) and anodized in six colors (light blue, silver, purple, blue, gold and green). The plates and screws are single use only, non-sterile products. They must be sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial and mandible
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)
The following tests were performed to validate the performance and the safety of the subject device and the test results supported substantial equivalence to the predicate devices.
- 4-Point Bending test in accordance with ASTM F382-99(2008)e1
- Torsion and Axial Pullout Strength Test in accordance with ASTM F543-13e1
- Cytotoxicity test in accordance with ISO 10993-5
- Sensitization test in accordance with ISO 10993-10
- Genotoxicity test in accordance with ISO 10993-3
- Implantation test in accordance with ISO 10993-6
- Sterilization validation test in accordance with ANSI/AAMI ST79, ISO 17665-1. ISO 11737-1, and USP 30-NF25 Microbial Limited Test.
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.
K112457, K113567, K121589, K953806, K983485, K963030, K040272, K091679
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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stylized to resemble a bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2015
Osteonic Co., Ltd C/O Ms. Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste. 110 Fullerton, CA 92831
Re: K140037
Trade/Device Name: Optimus CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: December 9, 2014 Received: December 12, 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.
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 yours,
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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Indications for Use
510(k) Number (if known) K140037
Device Name OPTIMUS CMF SYSTEM
Indications for Use (Describe)
Optimus CMF System is implantable bone screws for maxillofacial and mandible surgery procedures including: 1. Fractures
-
- Osteotomies
-
- Reconstructive procedures
-
- Revision procedures where other treatments or devices have failed.
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)
3
510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date:
1. Applicant / Submitter:
OSTEONIC Co., Ltd. 505-3Ho, Digital-ro 29-gil, Guro-gu, Seoul, Republic of Korea 152-779 Tel: +82-2-6082-8885
2. Submission Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110. Fullerton CA 92831 Email: juhee.c@lkconsultinggroup.com
3. Device:
- · Proprietary Name OPTIMUS CMF SYSTEM
- Common Name Dental Bone Plate & Screw System
- · Classification Name Dental Bone Plate
- Screw, fixation, intraosseous
4. Predicate Device:
- · LeForte System Bone Plate & Screw by Jeil Medical Corporation (K112457)
- · Synthes Matrix Mandibule Plate and Screw System by Synthes Inc. ( K113567)
- · Biomet Microfixation Facial Plating System by Biomet Microfixation (K121589)
- = Synthes (USA) Midfacial System by Synthes (USA) (K953806)
- = Synthes 1.3mm Self-Drilling Screw by Synthes (USA) (K983485)
- Leibinger IMF Screw by Howmedical Leibinger, Inc. (K963030)
- = Synthes (USA) Craniofacial Plates by Synthes (USA) (K040272)
- · Leforte System Bone Plate by Jeil Medical Coporation (K091679)
5. Product Code & Regulation Number:
- · JEY (21CFR872.4760)
- · DZL (21CFR872.4880)
6. Description:
The OPTIMUS CMF SYSTEM comprises plates and screws. The plate thickness sizes range from 0.4 to 2.6mm. They are made of unalloyed Titanium (ASTM F67) and anodized in
4
four colors (silver, blue, green, and gold). The diameters of the screws range from 1.3 to 2.7mm, while lengths range from 3.0 to 20.0mm. They are made of Ti-6A1-4V ELI titanium alloy (ASTM F136) and anodized in six colors (light blue, silver, purple, blue, gold and green). The plates and screws are single use only, non-sterile products. They must be sterilized before use.
7. Indication for use:
Optimus CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:
-
- Fractures
-
- Osteotomies
-
- Reconstructive procedures
-
- Revision procedures where other treatments or devices have failed.
8. Non-Clinical Testing:
The following tests were performed to validate the performance and the safety of the subject device and the test results supported substantial equivalence to the predicate devices.
- י 4-Point Bending test in accordance with ASTM F382-99(2008)e1
- י Torsion and Axial Pullout Strength Test in accordance with ASTM F543-13e1
- Cytotoxicity test in accordance with ISO 10993-5 י
- ' Sensitization test in accordance with ISO 10993-10
- י Genotoxicity test in accordance with ISO 10993-3
- 트 Implantation test in accordance with ISO 10993-6
- י Sterilization validation test in accordance with ANSI/AAMI ST79, ISO 17665-1. ISO 11737-1, and USP 30-NF25 Microbial Limited Test.
9. Substantial Equivalence:
The subject and predicate device(s) share the same intended use, primary design and equivalent material of manufacture. Any minor differences do not impact device performance as compared to the predicate devices and demonstrate that the Optimus CMF System is substantially equivalent to the predicate devices. The performance test results support that the subject device performs as well as the predicate devices.
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| Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Predicate Device 4 | Predicate Device 5 | Predicate Device 6 | Predicate Device 7 | Predicate Device 8 | |
|---|---|---|---|---|---|---|---|---|---|
| Company | OSTEONIC | ||||||||
| Co., Ltd. | Jeil Medical | ||||||||
| corporation | Synthes | Biomet | |||||||
| Microfixation | Synthes | Synthes | Howmedica | ||||||
| Leibinger Inc. | Synthes | Jeil Medical | |||||||
| Coporation | |||||||||
| Device | |||||||||
| Name | OPTIMUS | ||||||||
| CMF | |||||||||
| SYSTEM | LeForte System | ||||||||
| Bone Plate & | |||||||||
| Screw | MatrixMANDI | ||||||||
| BULE Plate | |||||||||
| and Screw | |||||||||
| System | Biomet | ||||||||
| Microfixation | |||||||||
| Facial Plating | |||||||||
| System | SYNTHES | ||||||||
| (USA) | |||||||||
| MIDFACIAL | |||||||||
| SYSTEM | Synthes | ||||||||
| 1.3mm Self- | |||||||||
| Drilling | |||||||||
| Screw | Leibinger IMF | ||||||||
| Sscerw | SYNTHES | ||||||||
| (USA) | |||||||||
| CRANIOFACI | |||||||||
| AL PLATES | LEFORTE | ||||||||
| SYSTEM | |||||||||
| BONE PLATE | |||||||||
| 510(K) # | N/A | K112457 | K113567 | K121589 | K953806 | K983485 | K963030 | K040272 | K091679 |
| Class | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
| Product | |||||||||
| Code | JEY, DZL | JEY, DZL | JEY | JEY | JEY | DZL | DZE | JEY | JEY |
| Intended | |||||||||
| Use | Optimus CMF | ||||||||
| System is | |||||||||
| implantable | |||||||||
| bone plates | |||||||||
| and bone | |||||||||
| screws for | |||||||||
| maxillofacial | |||||||||
| and mandible | |||||||||
| surgery | |||||||||
| procedures | |||||||||
| including: |
- Fractures
- Osteotomies
Reconstructive
procedures
4. Revision
procedures
where other
treatments or
devices have
failed. | This device is
intended for use
in selective
trauma of the
mid-face,
reconstruction
procedures and
selective
orthognathic
surgery of the
maxilla and chin | The
SynthesMatrix
MANDI BULE
Plate and
Screw System
is intended for
oral,
maxillofacial
surgery:
• Trauma
• Reconstructi-
ve surgery
• Orthognatic
surgery
(surgical
correction of
deformities) | These devices are
implantable bone
plates and bone
screws for facial
procedures
including:
- Fractures
- Osteotomies
- Reconstructive
procedures - Revision
procedures where
other treatments
or devices have
failed | Intended for use
in selective
trauma of the
midface and
craniofacial
skeleton;
craniofacial
surgery;
reconstructive
procedures and
selective
orthognathic
surgery of the
maxilla and
chin. | Synthes
1.3mm Self-
Drilling
Screws are
intended for
selective
trauma of the
midface and
craniofacial
skeleton:
craniofacial
surgery;
reconstructive
procedures;
and selective
orthognathic
surgery of the
maxilla and
chin. | Intended for
use in
temporary
maxillomandib
ular fixation to
provide indirect
stabilization of
the maxilla,
mandible or
both. | Intended for
use in selective
trauma of the
midface and
craniofacial
skeleton;
craniofacial
surgery;
reconstructive
procedures and
selective
orthognathic
surgery of the
maxilla and
chin. | This device is
intended for
use in selective
trauma of the
mid-face and
craniofacial
skeleton
craniofacial
surgery
reconstruction
procedures and
selective
orthognathic
surgery of the
maxilla and
chin |
| Material | Plate -
Unalloyed
Titanium
Screw-
Titanium Alloy | Plate -Unalloyed
Titanium
Screw- Titanium
Alloy | Unalloyed
Titanium | Plate - Unalloyed
Titanium
Screw- Titanium
Alloy | Unalloyed
Titanium | Titanium
Alloy | Titanium Alloy | Unalloyed
Titanium | Unalloyed
Titanium |
| Surface | Anodizing | Plate: Anodizing
Screw: N/A | Anodizing | Plate: N/A
Screw: Anodizing | Anodizing | Anodizing | - | Anodizing | Plate:
Anodizing |
| Anodizing
color | Light blue,
silver, purple, | Silver, blue,
green and gold | Silver, blue,
green and gold | Silver, magenta,
blue, green and | Silver, blue,
green and gold | Silver, blue,
green and gold | - | Silver, blue,
green and gold | Silver, blue,
green and gold |
| | blue, gold and
green | | | gold | | gold | | | |
| Single Use | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Sterile | Non sterile | Non sterile | Sterile or non-
sterile | Non sterile | Non sterile | Non sterile | Non sterile | Non sterile | Non sterile |
| Shape and
Dimension
of plate | Plate has
various shapes,
length and
thickness.
Straight, Y, D-
Y, X, L, Z,
Square,
Matrix,
Orbital, Chin
and
Reconstruction
types with
various
lengths. The
range of
plate's profile
is from 0.4 to
2.6mm
thickness and
4 colors
(silver, blue,
green and
gold). | Length
5.2223.5mm2.5mm | The system
Thickness
0.2
consists of a
variety of
plates offered
in multiple
shape and sizes
and a variety of
screws offered
in multiple
diameters and
lengths to meet
the anatomical
needs of the
patient. | The plates that
are the subject of
this 510(k)
submission
include variations
of straight, angle,
curved, L-shape,
T-shape, double
T-shape, Z-shape,
X-shape, Y-shape,
double Y-shape,
H-shape, triangle,
square, rectangle,
matrix, mesh,
orbital floor,
LeFort, and chin
options with
various lengths
and thickness.
Plates are offered
flat or pre-bent. | The plate size is
available in a
variety of
configurations
to accommodate
various fracture
sites. | - | - | The synthes
double
adaption plate
can be cut or
trimmed to the
desired length
to
accommodate
various
fractures and
meet the
anatomical
need of the
patient. The
plate has a low
profile head,
uses 2.0mm
self-tapping or
self-drilling
bone screw
and 2.4mm
emergency
screw. | The system
consists of a
variety of
plates offered
in multiple
shape and
sizes. |
| Screw
Sizes | The diameter
of screw is
from 1.3 to
2.7mm in
lengths of 3.0
to 20.0mm and
6 colors (light
blue, silver,
purple, blue,
gold and
green). | Outer(head)
diameter
1.22.65mm1.6mm
Inner diameter
0.7
Length
4.018.0mm | | Screw range in6mm | 2.0mm in
diameters of
1.0mm to 2.3mm
and lengths from
2.0mm to
29.0mm | Screw size is 1.3
or 1.5mm. | Available in
lengths
ranging from
4
diameter and
ranges from
10.5 to 8.5mm
in total
length(6~14m
m in thread
length) | - | |
6
7
10. Conclusions:
The subject and predicate device(s) share the same intended use, primary design and equivalent material of manufacture. The information provided in this submission including various test results support that the subject device is substantially equivalent to the predicate devices in the market.