OPTIMUS CMF SYSTEM

• K Number: K160363
• Device Name: OPTIMUS CMF SYSTEM
• Manufacturer: OSTEONIC Co., Ltd.
• Date Cleared: 2016-10-20 ( 254 days)
• Product Code: JEY DZL
• Regulation Number: 872.4760

Intended Use

Optimus CMF System is implantable bone plates and 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.

Device Description

The system is comprised of plate and screw. The range of subject device plate's sizes is from 0.6 to 1.5mm thick. It is made of unalloyed Titanium (ASTM F67) and anodized in 4 colors (silver, blue, green and gold). The range of screw's diameters is from 1.3 to 2.0mm in lengths of 6.0 to 12mm. The screws are made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and anodized in 3 colors (light blue, silver and gold). The device is packed separately in a PE bag.The plate and screw aresingle use only, nonsterile products. The devices must be sterilized before use. The screws are anodized in different colors to prevent confusion. The colors are selected for each model by diameter and so on. The devices are used as a pair (O-plate & O-screw, Fplate & F-screw) but sold individually (Not a kit or a set). The IMF screw is for maxillomandibular fixation. The head has a relief groove in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. It is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. It is used independently, not with the plates.

Predicate Devices

K140037-OPTIMUS CMF SYSTEM

Reference Devices

K112457-LeForte System Bone Plate & Screw

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and mechanical properties of bone plates and screws, with no mention of AI or ML.

Therapeutic

No
The device is described as implantable bone plates and screws used for fixation in maxillofacial and mandible surgery, not as a device that delivers a therapeutic substance or energy.

Diagnostic

No

The device description indicates that the Optimus CMF System consists of implantable bone plates and screws used for orthopedic fixation in maxillofacial and mandible surgery procedures, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of physical components: implantable bone plates and bone screws made of titanium.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 information is used for diagnosis, monitoring, or screening.
• Device Description and Intended Use: The Optimus CMF System is described as implantable bone plates and bone screws used in surgical procedures on the maxillofacial and mandible areas. Its purpose is to fix fractures, perform osteotomies, and aid in reconstructive and revision procedures.
• Mechanism of Action: The device works by providing structural support and fixation to bone, not by analyzing biological samples.

The description clearly indicates a surgical implant used directly on the patient's bone, which falls under the category of surgical devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Optimus CMF System is implantable bone plates and 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 system is comprised of plate and screw. The range of subject device plate's sizes is from 0.6 to 1.5mm thick. It is made of unalloyed Titanium (ASTM F67) and anodized in 4 colors (silver, blue, green and gold). The range of screw's diameters is from 1.3 to 2.0mm in lengths of 6.0 to 12mm. The screws are made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and anodized in 3 colors (light blue, silver and gold).

The device is packed separately in a PE bag.The plate and screw aresingle use only, nonsterile products. The devices must be sterilized before use.

The screws are anodized in different colors to prevent confusion. The colors are selected for each model by diameter and so on. The devices are used as a pair (O-plate & O-screw, Fplate & F-screw) but sold individually (Not a kit or a set).

The IMF screw is for maxillomandibular fixation. The head has a relief groove in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. It is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. It is used independently, not with the plates.

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)

Non-clinical tests were performed:

• 4 Point Bending Test in accordance with ASTM F382-14 to evaluate strength (yield strength, bending structural stiffness, and bending strength)
• Torsional strength test and pullout force test in accordance with ASTM F 543 13 to evaluate strength

Key results: The test results of the subject device were overall higher than the predicatedevices supporting that the subject device is substantially equivalent to the predicate devices.

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.

K140037-OPTIMUS CMF SYSTEM

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.

K112457-LeForte System Bone Plate & Screw

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

§ 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.

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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

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

October 20, 2016

Osteonic Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt, Ste 417 Irvine, California 92620

Re: K160363

Trade/Device Name: Optimus CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: September 15, 2016 Received: September 20, 2016

Dear Priscilla 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.

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

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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 devicerelated 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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) K160363

Device Name Optimus CMF System

Indications for Use (Describe)

Optimus CMF System is implantable bone plates and 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.

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)

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K160363

510(k) Summary

Date: Oct 20, 2016

1. Applicant / Submitter:

Osteonic Co., Ltd. 1206ho, 38, Digital-ro 29-gil Guro-gu, Seoul, Korea, (Postcode 08381) Tel :[phone] Fax : [phone]

2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt, Ste 417 Irvine CA 92620 Tel: [phone] Email: [e-mail]

3. Device:

• Proprietary Name OPTIMUS CMF SYSTEM
• Common Name Dental Bone Plate & Screw System
• Classification Name Bone Plate

4. Predicate Device:

• Primary Predicate Device: K140037-OPTIMUS CMF SYSTEM by Osteonic Co., Ltd.
• Reference Predicate Device: K112457-LeForte System Bone Plate & Screw by Jeil Medical Corporation

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5. Product Code & Regulation Number:

• Primary JEY (21CFR 872.4760)
• Secondary DZL

6. Device Description:

The system is comprised of plate and screw. The range of subject device plate's sizes is from 0.6 to 1.5mm thick. It is made of unalloyed Titanium (ASTM F67) and anodized in 4 colors (silver, blue, green and gold). The range of screw's diameters is from 1.3 to 2.0mm in lengths of 6.0 to 12mm. The screws are made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and anodized in 3 colors (light blue, silver and gold).

The device is packed separately in a PE bag.The plate and screw aresingle use only, nonsterile products. The devices must be sterilized before use.

The screws are anodized in different colors to prevent confusion. The colors are selected for each model by diameter and so on. The devices are used as a pair (O-plate & O-screw, Fplate & F-screw) but sold individually (Not a kit or a set).

The IMF screw is for maxillomandibular fixation. The head has a relief groove in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. It is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. It is used independently, not with the plates.

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7. Indication for use:

Optimus CMF System is implantable bone plates and 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.

8. Non-clinical tests:

There are a number of differences between the unmodified devices and the modified devices as presented in this submission, however, the differences were evaluated through design control, risk analysis and verification & validation activities, and test results demonstrated that the differences do not raise a question of safety and effectiveness. The following tests were performed on the subject device and the predicate devices.

• 4 Point Bending Test in accordance with ASTM F382-14 to evaluate strength (yield strength, bending structural stiffness, and bending strength)
• Torsional strength test and pullout force test in accordance with ASTM F 543 13 to evaluate strength

The test results of the subject device were overall higher than the predicatedevices supporting that the subject device is substantially equivalent to the predicate devices. Validation of sterilization parameters and biocompatibility of the submission device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K140037.

9. Substantial Equivalence:

The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, raw material, and use concept and employ the same manufacturing processes including anodization and sterilization method. The differences are in shape and dimensions; however; the performance test data provided in this submission proves that this differences do not raise new issues in safety and performance.

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	Subject Device	Primary Predicate Device	Reference Device
510K Number	K160363	K140037	K112457
Product Code	JEY, DZL	JEY, DZL	JEY, DZL
Manufacturer	OSTEONIC Co., Ltd.		Jeil Medical Corporation
Indications for
Use	Optimus CMF System is implantable bone plates and
bone screws for maxillofacial and mandible surgery
procedures including:

1. Factures
2. Osteotomies
3. 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. |
   | Materials | Unalloyed Titanium and Titanium alloy | | Unalloyed Titanium and
   Titanium alloy |
   | Shape | • Plate
   Leforte I,
   Segmentalleforte I,
   Buttress,
   T
   and Straight types with
   various lengths. | • Plate
   Straight,
   Y,
   D-Y,
   X,
   L,
   Z,
   Square,
   Matrix,
   Orbital,
   Chin
   and Reconstruction types
   with various lengths. | • Plate
   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,
   Orbital Mesh, A, Angled
   Locking, Prebending L,
   Curved Locking, Straight
   reconstruction Locking,
   Straight BSSO Locking,
   Angled Reconstruction
   Locking, Multi
   Reconstruction Locking,
   Straight Locking |
   | | • Screw
   Pre-drilling screw,
   Self-drilling screw,
   IMF screw | • Screw
   Pre-drilling screw,
   Self-drilling screw,
   IMF screw | • Screw
   Common screw-Micro,
   Common screw-Mid,
   Common screw-Mini |
   | | | | |
   | | | | Common screw-Maxi,
   Auto screw-Micro, Auto
   screw-Mid, Auto screw-
   Mini, Mini Locking Auto
   screw, Maxi Locking Auto
   screw, Mini Locking
   Common screw, Maxi
   Locking common screw |
   | Dimensions | • Plate
   The plate thickness sizes
   range from 0.6 to 1.5mm.
   Length:21.536.5
   Width: 4.530.00
   • Screw
   The diameters of the
   screws range from 1.3 to
   2.0mm while lengths
   range from 6.0 to
   12.0mm.
   (1) Pre-drilling screw
   Diameter: Ø1.3mm
   Length: 10.0, 12.0mm
   (2) Self-drilling screw
   Diameter: Ø1.3mm
   Length: 8.0, 10.0mm
   (3) IMF screw
   Diameter: Ø2.0mm
   Length: 6.0, 8.0, 10.0,
   12.0mm | • Plate
   The plate thickness sizes
   range from 0.4 to 2.6mm.
   Length: 11.639.9mm
   Width: 3.1 243.3mm
   • Screw
   The diameters of the
   screws range from 1.3 to
   2.7mm while lengths
   range from 3.0 to
   20.0mm.
   (1)Pre-drilling screw
   Diameter: Ø1.3 Ø2.7mm
   Length: 3.020.0mm
   (2) Self-drilling screw
   Diameter: Ø1.3~ Ø1.95mm
   Length: 3.014.0mm
   (3) IMF screw
   Diameter: Ø 1.6 Ø2.0mm
   Length: 6.012.0mm | • Plate
   Plate length 5.2223.5mm
   Thickness 0.22.5mm
   • Screw
   Screw outer(head)
   diameter 1.22.65mm,
   Inner diameter
   0.71.6mm,
   Length 4.018.0mm |
   | Surface
   Treatment | Anodizing | | Plate: Anodizing
   Screw: N/A |
   | Anodizing Color | • Plate
   Silver, blue, green and gold
   • Screw
   Light blue, silver and gold | • Plate
   Silver, blue, green and
   gold
   • Screw
   Light blue, silver, purple,
   blue, gold and green | • Plate
   Light blue, silver and gold
   • Screw
   N/A |

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Sterilization	Non-sterile products	Non sterile
Usage	Single use only	Single use
Packaging	1EA/bag	1EA/bag

Conclusions: 10.

Based on documentation supplied with this submission, conclusions drawn from design control, risk analysis and verification & validation activities demonstrate that the subject devices are substantially equivalent to the predicate device.