4CIS® Pinehurst Anterior Cervical Plate system

K182489 · Solco Biomedical Co., Ltd. · KWQ · Jan 16, 2019 · Orthopedic

Device Facts

• Record ID: K182489
• Device Name: 4CIS® Pinehurst Anterior Cervical Plate system
• Applicant: Solco Biomedical Co., Ltd.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.

Device Story

Anterior cervical plate system for spinal fixation; provides temporary stabilization during fusion development. Components include titanium alloy plates, bone screws, and pre-assembled locking caps to prevent screw back-out. Used by surgeons via anterior approach to vertebral bodies. Rigid fixation achieved through screw-plate construct; configuration tailored to patient anatomy and pathology. Benefits include stabilization of cervical spine segments to facilitate fusion. Non-sterile, single-use device.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic compression bending, static tension bending, and static torsion testing in accordance with ASTM F1717. No clinical data provided.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Design: Anterior cervical plate with pre-assembled locking caps for screw retention. Energy source: None (mechanical). Connectivity: None. Sterilization: Provided non-sterile, intended for single use.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-T1) during fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma/fractures, spinal stenosis, tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, and failed previous fusions.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 16, 2019

Solco Biomedical Co., Ltd. % Mr. Hwi Joon Park Manager First Gold Corporation 14110 Dallas Parkway, Suite 135 Dallas, Texas 75254

Re: K182489

Trade/Device Name: 4CIS® Pinehurst Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 18, 2018 Received: December 20, 2018

Dear Mr. Park:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K182489

Device Name

4CIS® Pinehurst Anterior Cervical Plate system

Indications for Use (Describe)

The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K182489

## 510(k) Summary

| Submitter | Solco Biomedical Co., Ltd.<br>154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do, 17704<br>Republic of Korea<br>Phone. [phone]<br>Fax. [phone] |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | HWI JOON, PARK<br>14110 Dallas Pkwy Suite 135, Dallas, Texas 75254 USA<br>Phone: [phone]<br>Fax: [phone] |
| Submission Date | Sep 04, 2018 |
| Trade / Proprietary name | 4CIS® Pinehurst Anterior Cervical Plate system |
| Common / Usual Name | Intervertebral body fixation orthosis |
| Classification Name | Spinal Intervertebral Body Fixation Orthosis |
| Classification Code | KWQ |
| Regulatory Class | Class II |
| Regulation Number | 888.3060 |

{4}------------------------------------------------

| Description of Device | The 4CIS® Pinehurst Anterior Cervical Plate system is intended for<br>anterior cervical intervertebral body screw fixation from C2 to T1.<br>Rigid fixation is provided by bone screws inserted into the vertebral<br>body of the cervical spine using an anterior approach.<br>Implant components consist of a variety of shapes and sizes of plates.<br>bone screws and associated instruments. Locking caps are pre-<br>assembled to the plates. They cover the heads of the bone screws to<br>reduce the potential for screw back-out.<br>With this locking mechanism, implant components can be rigidly<br>locked into many different configurations to suit the individual<br>pathology and anatomical conditions of the mature patient.<br>They are made of titanium alloy (Ti-6AI-4V ELI) per ASTM F136.<br>Implants must not be used with the components from any other<br>system or manufacturer in a construct. |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The 4CIS® Pinehurst Anterior Cervical Plate system is intended for<br>anterior interbody screw fixation from C2 to T1. The system is indicated<br>for use in the temporary stabilization of the anterior spine during the<br>development of cervical spinal fusions in patients with: 1) degenerative<br>disc disease (as defined by neck pain of discogenic origin with<br>degeneration of the disc confirmed by patient history and radiographic<br>studies), 2) Spondylolisthesis, 3) trauma (including fractures), 4) Spinal<br>Stenosis, 5) tumors, 6) deformity (defined as kyphosis, lordosis, or<br>scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions. |
| Comparison of<br>Technological<br>Characteristics with the<br>Predicate Devices | Indication for Use<br>The subject 4CIS® Pinehurst Anterior Cervical Plate system and all the<br>predicates have the same or similar indications for use statements.<br>Materials<br>The subject device is composed of the same material as the predicate<br>devices conforming to recognized industry standards for permanent<br>implants and surgical orthopedic instruments.<br>Design Features/Functions<br>The subject 4CIS® Pinehurst Anterior Cervical Plate system and cited<br>predicate devices share similar basic design features and functions.<br>Dimensions<br>The subject 4CIS® Pinehurst Anterior Cervical Plate system is<br>dimensionally similar to cited predicate devices.<br>Sterilization<br>The subject 4CIS® Pinehurst Anterior Cervical Plate system and cited<br>predicate devices are provided non-sterile for single use only.<br>Performance Specification<br>Mechanical testing confirmed 4CIS® Pinehurst Anterior Cervical Plate<br>system demonstrated equivalent performance to the cited predicate<br>device under the same test conditions. |
| Performance Data | Mechanical testing (static and dynamic compression bending, static<br>tension bending, static torsion) was conducted in accordance with<br>ASTM F1717.<br>Above non-clinical performance data in the form of a comprehensive<br>literature review was provided in support of substantial equivalence of<br>the subject device. |
| Conclusion | The overall technology characteristics and mechanical performance data<br>lead to the conclusion that 4CIS® Pinehurst Anterior Cervical Plate<br>system is substantially equivalent to legally marketed predicate devices<br>for intended use, material composition, principles of operation, and<br>design. |

{5}------------------------------------------------