OPTIMUS NEURO SYSTEM

K141911 · Osteonic Co., Ltd. · GWO · Feb 10, 2015 · Neurology

Device Facts

• Record ID: K141911
• Device Name: OPTIMUS NEURO SYSTEM
• Applicant: Osteonic Co., Ltd.
• Product Code: GWO · Neurology
• Decision Date: Feb 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Optimus Neuro System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

Device Story

Optimus Neuro System comprises titanium plates and screws for cranial bone fixation; stabilization; and fracture alignment. Plates (0.3-0.6mm thick) and screws (0.8-1.8mm diameter; 3.0-6.0mm length) are manually placed by surgeons during cranial surgery. Plates may be bent or cut to match patient anatomy; screws are inserted through plate holes into bone. Device is non-sterile; requires user sterilization before use. Provides mechanical support for bone healing in reconstructive procedures.

Clinical Evidence

Bench testing only. Testing included sterilization validation (SAL 10^-6), mechanical performance testing, cleaning process validation (endotoxin levels < 2.15 EU/device), and packaging integrity testing. All tests met pre-set acceptance criteria.

Technological Characteristics

Plates: Commercially pure titanium (ASTM F67, Gr 1, 2, 3). Screws: Ti-6Al-4V ELI titanium alloy (ASTM F136). Anodized finish. Non-sterile; user-sterilized via steam. Manual fixation system.

Indications for Use

Indicated for patients requiring fixation, alignment, and stabilization of fractures in the cranial skeleton during cranial surgery or reconstructive procedures.

Regulatory Classification

Identification

A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Neuro plating system (K121624)
• LEFORTE NEURO SYSTEM BONE PLATE and SCREW (K112812)
• Frontier Devices Neuro Closure System (K100205)

Submission Summary (Full Text)

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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 consists of a stylized caduceus symbol, which features three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

February 9, 2015

OSTEONIC Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E Chapman Ave. Suite 110 Fullerton, California 92831

Re: K141911

> Trade/Device Name: OPTIMUS NEURO SYSTEM Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GRX, HBW Dated: January 5. 2015 Received: January 8, 2015

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.

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

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to remarket 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,

Carlos L. Pena -SFD/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K141911

Device Name

Optimus Neuro System

Indications for Use (Describe)

Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.

| 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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## 510(k) Summary (K141911)

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 02/08/2015

## 1. 510K Applicant

OSTEONIC Co., Ltd.

505-3Ho, Digital-ro 29-gil, Guro-gu, Seoul, Republic of Korea Tel: [phone] Fax: [phone]

## 2. US Agent/ Correspondent

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

## 3. Device

- Trade Name: OPTIMUS NEURO SYSTEM
- Classification Name: Neuro Plating System
- · Classification regulation: 21CFR§882.5320
- 21CFR § 882.5250 21CFR §882.5360 • Product Code: GWO, GRX, HBW

### 4. Predicate Device:

- · Neuro plating system (K121624) by Biomet Microfixation
- LEFORTE NEURO SYSTEM BONE PLATE and SCREW (K112812) by Jeil Medical Corporation
- · Frontier Devices Neuro Closure System (K100205) by Frontier Devices

### 5. Device Description:

The Optimus Neuro System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in

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lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag.

Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.

## 6. Indications for use:

Optimus Neuro System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

## 7. Comparison to the Cleared Device

The subject device is similar to the predicate devices in terms of indications, materials, and design. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. There might be slight differences in dimensions and shapes between the subject device and each predicate device; however, the test results of non-clinical testing including mechanical testing provided in this submission proves substantial equivalence to the predicate devices.

## 8. Performance Data

| Test | Result | Conclusion |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Sterilization Validation Test | Sterility assurance level(106)<br>for the recommended steam<br>sterilization parameters is<br>met. | The recommended sterilization<br>parameters for the user are<br>valid. |
| Mechanical Test | Worst case test articles have<br>passed the pre-set criteria. | The subject devices have been<br>validated in mechanical<br>characteristics. |
| Cleaning Process Validation<br>Test | The subject devices showed low<br>bioburden level and met<br>criteria of 2.15 EU/device for<br>endotoxin. | The cleaning process at the<br>manufacturing sites has been<br>validated. |
| Packaging Validation Test | Final packaging of the subject<br>device has passed the testing for<br>its complete sealing. | The subject device will be well<br>protected until use in its<br>packaging. |

The following bench tests have been performed on the subject device and passed the pre-set criteria.

## 9. Conclusion

Based on the non-clinical testing data and the information provided in the submission, we have concluded that our devices are substantially equivalent to the predicate devices in the market. No new questions of safety and effectiveness have been raised.