OPTIMUS CMF SYSTEM

K160363 · Osteonic Co., Ltd. · JEY · Oct 20, 2016 · Dental

Device Facts

• Record ID: K160363
• Device Name: OPTIMUS CMF SYSTEM
• Applicant: Osteonic Co., Ltd.
• Product Code: JEY · Dental
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Special
• 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 unalloyed titanium bone plates (0.6-1.5mm thick) and Ti-6Al-4V ELI titanium alloy bone screws (1.3-2.0mm diameter, 6.0-12mm length). IMF screws feature a relief groove for wire/elastic band attachment for temporary maxillomandibular fixation. Devices are non-sterile, single-use, and require sterilization by the user. Used in maxillofacial and mandible surgery to provide stabilization for fractures, osteotomies, and reconstructions. Surgeons select components based on anatomical requirements; screws are color-coded by diameter to prevent confusion. System provides mechanical fixation to support bone healing.

Clinical Evidence

Bench testing only. Performance evaluated via 4-point bending tests (ASTM F382-14) and torsional/pullout force tests (ASTM F543-13). Subject device performance met or exceeded predicate device results.

Technological Characteristics

Materials: Unalloyed Titanium (ASTM F67) for plates, Ti-6Al-4V ELI (ASTM F136) for screws. Anodized surface treatment. Mechanical fixation via plates and screws. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring maxillofacial and mandible surgery, including fracture repair, osteotomies, reconstructive procedures, and revision surgeries.

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

• OPTIMUS CMF SYSTEM (K140037)

Reference Devices

• LeForte System Bone Plate & Screw (K112457)

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

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<br>Use | Optimus CMF System is implantable bone plates and<br>bone screws for maxillofacial and mandible surgery<br>procedures including:<br>1. Factures<br>2. Osteotomies<br>3. Reconstructive procedures<br>4. Revision procedures where other treatments or devices<br>have failed. | | This device is intended for<br>use in selective trauma of<br>the mid-face,<br>reconstruction procedures<br>and selective orthognathic<br>surgery of the maxilla and<br>chin. |
| Materials | Unalloyed Titanium and Titanium alloy | | Unalloyed Titanium and<br>Titanium alloy |
| Shape | • Plate<br>Leforte I,<br>Segmentalleforte I,<br>Buttress,<br>T<br>and Straight types with<br>various lengths. | • Plate<br>Straight,<br>Y,<br>D-Y,<br>X,<br>L,<br>Z,<br>Square,<br>Matrix,<br>Orbital,<br>Chin<br>and Reconstruction types<br>with various lengths. | • Plate<br>L, T, Mesh, Straight, Y, H,<br>Curved, Square, Quad, X,<br>Calvarium, Hexagon,<br>Double Y, RC, Z, I,<br>Compression, Chin, Rigid<br>straight, BSSO, Angled<br>Reconstruction, MG,<br>Orbital Mesh, A, Angled<br>Locking, Prebending L,<br>Curved Locking, Straight<br>reconstruction Locking,<br>Straight BSSO Locking,<br>Angled Reconstruction<br>Locking, Multi<br>Reconstruction Locking,<br>Straight Locking |
| | • Screw<br>Pre-drilling screw,<br>Self-drilling screw,<br>IMF screw | • Screw<br>Pre-drilling screw,<br>Self-drilling screw,<br>IMF screw | • Screw<br>Common screw-Micro,<br>Common screw-Mid,<br>Common screw-Mini |
| | | | |
| | | | Common screw-Maxi,<br>Auto screw-Micro, Auto<br>screw-Mid, Auto screw-<br>Mini, Mini Locking Auto<br>screw, Maxi Locking Auto<br>screw, Mini Locking<br>Common screw, Maxi<br>Locking common screw |
| Dimensions | • Plate<br>The plate thickness sizes<br>range from 0.6 to 1.5mm.<br>Length:21.5~36.5<br>Width: 4.5~30.00<br>• Screw<br>The diameters of the<br>screws range from 1.3 to<br>2.0mm while lengths<br>range from 6.0 to<br>12.0mm.<br>(1) Pre-drilling screw<br>Diameter: Ø1.3mm<br>Length: 10.0, 12.0mm<br>(2) Self-drilling screw<br>Diameter: Ø1.3mm<br>Length: 8.0, 10.0mm<br>(3) IMF screw<br>Diameter: Ø2.0mm<br>Length: 6.0, 8.0, 10.0,<br>12.0mm | • Plate<br>The plate thickness sizes<br>range from 0.4 to 2.6mm.<br>Length: 11.6~39.9mm<br>Width: 3.1 ~243.3mm<br>• Screw<br>The diameters of the<br>screws range from 1.3 to<br>2.7mm while lengths<br>range from 3.0 to<br>20.0mm.<br>(1)Pre-drilling screw<br>Diameter: Ø1.3~ Ø2.7mm<br>Length: 3.0~20.0mm<br>(2) Self-drilling screw<br>Diameter: Ø1.3~ Ø1.95mm<br>Length: 3.0~14.0mm<br>(3) IMF screw<br>Diameter: Ø 1.6~ Ø2.0mm<br>Length: 6.0~12.0mm | • Plate<br>Plate length 5.2~223.5mm<br>Thickness 0.2~2.5mm<br>• Screw<br>Screw outer(head)<br>diameter 1.2~2.65mm,<br>Inner diameter<br>0.7~1.6mm,<br>Length 4.0~18.0mm |
| Surface<br>Treatment | Anodizing | | Plate: Anodizing<br>Screw: N/A |
| Anodizing Color | • Plate<br>Silver, blue, green and gold<br>• Screw<br>Light blue, silver and gold | • Plate<br>Silver, blue, green and<br>gold<br>• Screw<br>Light blue, silver, purple,<br>blue, gold and green | • Plate<br>Light blue, silver and gold<br>• Screw<br>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.