OPTIMUS CMF SYSTEM

K140037 · Osteonic Co., Ltd. · JEY · Jan 20, 2015 · Dental

Device Facts

• Record ID: K140037
• Device Name: OPTIMUS CMF SYSTEM
• Applicant: Osteonic Co., Ltd.
• Product Code: JEY · Dental
• Decision Date: Jan 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Optimus CMF System consists of implantable bone plates and screws for maxillofacial and mandible surgery. Plates (0.4-2.6mm thick) and screws (1.3-2.7mm diameter; 3.0-20.0mm length) are used by surgeons to stabilize bone segments during fracture repair, osteotomies, or reconstructive procedures. Devices are non-sterile and require sterilization before use. Surgeons select appropriate plate shapes and screw sizes based on anatomical needs. The system provides mechanical fixation to support bone healing and structural restoration.

Clinical Evidence

Bench testing only. Performance validated via 4-Point Bending (ASTM F382-99), Torsion and Axial Pullout Strength (ASTM F543-13e1), and biocompatibility testing (ISO 10993-5, -10, -3, -6). Sterilization validated per ANSI/AAMI ST79 and ISO 17665-1.

Technological Characteristics

Plates: Unalloyed Titanium (ASTM F67). Screws: Ti-6Al-4V ELI titanium alloy (ASTM F136). Surface treatment: Anodizing. Mechanical fixation via bone plates and screws. Non-sterile, single-use. Various shapes (straight, Y, X, L, Z, etc.) and dimensions.

Indications for Use

Indicated for patients requiring maxillofacial and mandible surgery for fractures, osteotomies, reconstructive procedures, or revision procedures following failed treatments.

Regulatory Classification

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

- 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)

# 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)

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# 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: [phone]

#### 2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110. Fullerton CA 92831 Email: [e-mail]

#### 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

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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:

- 1. Fractures
- 2. Osteotomies
- 3. Reconstructive procedures
- 4. 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 <61> 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<br>Co., Ltd. | Jeil Medical<br>corporation | Synthes | Biomet<br>Microfixation | Synthes | Synthes | Howmedica<br>Leibinger Inc. | Synthes | Jeil Medical<br>Coporation |
| Device<br>Name | OPTIMUS<br>CMF<br>SYSTEM | LeForte System<br>Bone Plate &<br>Screw | MatrixMANDI<br>BULE Plate<br>and Screw<br>System | Biomet<br>Microfixation<br>Facial Plating<br>System | SYNTHES<br>(USA)<br>MIDFACIAL<br>SYSTEM | Synthes<br>1.3mm Self-<br>Drilling<br>Screw | Leibinger IMF<br>Sscerw | SYNTHES<br>(USA)<br>CRANIOFACI<br>AL PLATES | LEFORTE<br>SYSTEM<br>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<br>Code | JEY, DZL | JEY, DZL | JEY | JEY | JEY | DZL | DZE | JEY | JEY |
| Intended<br>Use | Optimus CMF<br>System is<br>implantable<br>bone plates<br>and bone<br>screws for<br>maxillofacial<br>and mandible<br>surgery<br>procedures<br>including:<br>1. Fractures<br>2. Osteotomies<br>3.<br>Reconstructive<br>procedures<br>4. Revision<br>procedures<br>where other<br>treatments or<br>devices have<br>failed. | This device is<br>intended for use<br>in selective<br>trauma of the<br>mid-face,<br>reconstruction<br>procedures and<br>selective<br>orthognathic<br>surgery of the<br>maxilla and chin | The<br>SynthesMatrix<br>MANDI BULE<br>Plate and<br>Screw System<br>is intended for<br>oral,<br>maxillofacial<br>surgery:<br>• Trauma<br>• Reconstructi-<br>ve surgery<br>• Orthognatic<br>surgery<br>(surgical<br>correction of<br>deformities) | These devices are<br>implantable bone<br>plates and bone<br>screws for facial<br>procedures<br>including:<br>1. Fractures<br>2. Osteotomies<br>3. Reconstructive<br>procedures<br>4. Revision<br>procedures where<br>other treatments<br>or devices have<br>failed | Intended for use<br>in selective<br>trauma of the<br>midface and<br>craniofacial<br>skeleton;<br>craniofacial<br>surgery;<br>reconstructive<br>procedures and<br>selective<br>orthognathic<br>surgery of the<br>maxilla and<br>chin. | Synthes<br>1.3mm Self-<br>Drilling<br>Screws are<br>intended for<br>selective<br>trauma of the<br>midface and<br>craniofacial<br>skeleton:<br>craniofacial<br>surgery;<br>reconstructive<br>procedures;<br>and selective<br>orthognathic<br>surgery of the<br>maxilla and<br>chin. | Intended for<br>use in<br>temporary<br>maxillomandib<br>ular fixation to<br>provide indirect<br>stabilization of<br>the maxilla,<br>mandible or<br>both. | Intended for<br>use in selective<br>trauma of the<br>midface and<br>craniofacial<br>skeleton;<br>craniofacial<br>surgery;<br>reconstructive<br>procedures and<br>selective<br>orthognathic<br>surgery of the<br>maxilla and<br>chin. | This device is<br>intended for<br>use in selective<br>trauma of the<br>mid-face and<br>craniofacial<br>skeleton<br>craniofacial<br>surgery<br>reconstruction<br>procedures and<br>selective<br>orthognathic<br>surgery of the<br>maxilla and<br>chin |
| Material | Plate -<br>Unalloyed<br>Titanium<br>Screw-<br>Titanium Alloy | Plate -Unalloyed<br>Titanium<br>Screw- Titanium<br>Alloy | Unalloyed<br>Titanium | Plate - Unalloyed<br>Titanium<br>Screw- Titanium<br>Alloy | Unalloyed<br>Titanium | Titanium<br>Alloy | Titanium Alloy | Unalloyed<br>Titanium | Unalloyed<br>Titanium |
| Surface | Anodizing | Plate: Anodizing<br>Screw: N/A | Anodizing | Plate: N/A<br>Screw: Anodizing | Anodizing | Anodizing | - | Anodizing | Plate:<br>Anodizing |
| Anodizing<br>color | Light blue,<br>silver, purple, | Silver, blue,<br>green and gold | Silver, blue,<br>green and gold | Silver, magenta,<br>blue, green and | Silver, blue,<br>green and gold | Silver, blue,<br>green and gold | - | Silver, blue,<br>green and gold | Silver, blue,<br>green and gold |
| | blue, gold and<br>green | | | gold | | gold | | | |
| Single Use | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Sterile | Non sterile | Non sterile | Sterile or non-<br>sterile | Non sterile | Non sterile | Non sterile | Non sterile | Non sterile | Non sterile |
| Shape and<br>Dimension<br>of plate | Plate has<br>various shapes,<br>length and<br>thickness.<br>Straight, Y, D-<br>Y, X, L, Z,<br>Square,<br>Matrix,<br>Orbital, Chin<br>and<br>Reconstruction<br>types with<br>various<br>lengths. The<br>range of<br>plate's profile<br>is from 0.4 to<br>2.6mm<br>thickness and<br>4 colors<br>(silver, blue,<br>green and<br>gold). | Length<br>5.2~223.5mm<br>Thickness<br>0.2~2.5mm | The system<br>consists of a<br>variety of<br>plates offered<br>in multiple<br>shape and sizes<br>and a variety of<br>screws offered<br>in multiple<br>diameters and<br>lengths to meet<br>the anatomical<br>needs of the<br>patient. | The plates that<br>are the subject of<br>this 510(k)<br>submission<br>include variations<br>of straight, angle,<br>curved, L-shape,<br>T-shape, double<br>T-shape, Z-shape,<br>X-shape, Y-shape,<br>double Y-shape,<br>H-shape, triangle,<br>square, rectangle,<br>matrix, mesh,<br>orbital floor,<br>LeFort, and chin<br>options with<br>various lengths<br>and thickness.<br>Plates are offered<br>flat or pre-bent. | The plate size is<br>available in a<br>variety of<br>configurations<br>to accommodate<br>various fracture<br>sites. | - | - | The synthes<br>double<br>adaption plate<br>can be cut or<br>trimmed to the<br>desired length<br>to<br>accommodate<br>various<br>fractures and<br>meet the<br>anatomical<br>need of the<br>patient. The<br>plate has a low<br>profile head,<br>uses 2.0mm<br>self-tapping or<br>self-drilling<br>bone screw<br>and 2.4mm<br>emergency<br>screw. | The system<br>consists of a<br>variety of<br>plates offered<br>in multiple<br>shape and<br>sizes. |
| Screw<br>Sizes | The diameter<br>of screw is<br>from 1.3 to<br>2.7mm in<br>lengths of 3.0<br>to 20.0mm and<br>6 colors (light<br>blue, silver,<br>purple, blue,<br>gold and<br>green). | Outer(head)<br>diameter<br>1.2~2.65mm<br>Inner diameter<br>0.7~1.6mm<br>Length<br>4.0~18.0mm | | Screw range in<br>diameters of<br>1.0mm to 2.3mm<br>and lengths from<br>2.0mm to<br>29.0mm | Screw size is 1.3<br>or 1.5mm. | Available in<br>lengths<br>ranging from<br>4~6mm | 2.0mm in<br>diameter and<br>ranges from<br>10.5 to 8.5mm<br>in total<br>length(6~14m<br>m in thread<br>length) | - | |

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#### 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.