4CIS® Marlin ACIF Cage System

K162402 · Solco Biomedical Co., Ltd. · ODP · Feb 16, 2017 · Orthopedic

Device Facts

• Record ID: K162402
• Device Name: 4CIS® Marlin ACIF Cage System
• Applicant: Solco Biomedical Co., Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Feb 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

Device Story

Hollow, rectangular intervertebral body fusion cage; implanted via open, anterior cervical approach; maintains disc space height post-discectomy until fusion occurs. Filled with autogenous or allogenic bone graft; used with supplemental cervical spinal fixation (e.g., anterior cervical plate). PEEK versions include tantalum x-ray markers for visualization. Surface teeth provide anchoring to prevent subsidence, slipping, or expulsion. Used by surgeons in clinical settings to treat degenerative disc disease; benefits patients by stabilizing the spinal segment to facilitate fusion.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic compression, static and dynamic torsion, static subsidence, and static expulsion testing in accordance with ASTM F2077 and ASTM F2267. No clinical data provided.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 or VESTAKEEP i4R (ASTM F2026) or Titanium alloy (ASTM F136); Tantalum markers (ASTM F560). Form factor: Hollow, rectangular cage with surface teeth. Sterilization: Provided sterile and non-sterile for single use. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at C2-C3 through C7-T1 levels, defined as discogenic neck pain with disc degeneration confirmed by history and radiography, following six weeks of failed non-operative therapy.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• SYNTHES ACIS/VERTEBRAL SPACER CR (K120275)
• Endoskeleton® TC (K100889)
• PATRIOT SPACERS: COLONIAL ACDF (K072991)
• Phantom™ Plus (K082801)
• TRYPTIK Ca (K091873)

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

February 16, 2017

Solco Biomedical Co., Ltd. % Hwi Joon Park Manager First Gold Corp. 14110 Dallas Pkwy, Suite 135 Dallas, Texas 75254

Re: K162402

Trade/Device Name: 4CIS® Marlin ACIF Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 11, 2016 Received: January 17, 2017

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

# Mark N. Melkerson -S

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

Enclosure

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### Indications for Use

510(k) Number (if known)

#### K162402

Device Name 4CIS® Marlin ACIF Cage System

#### Indications for Use (Describe)

4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

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

| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CEB 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |

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## 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 | Aug 23, 2016 |
| Trade / Proprietary name | 4CIS® Marlin ACIF Cage System |
| Common / Usual Name | Cervical Intervertebral Body Fusion Device |
| Classification Name<br>Classification Code<br>Regulatory Class<br>Regulation Number | Intervertebral Fusion Device With Bone Graft, Cervical<br>ODP<br>Class II<br>888.3080 |
| Predicate Device | SYNTHES ACIS/VERTEBRAL SPACER CR<br>(K120275, Primary)<br>Endoskeleton® TC (K100889, Additional)<br>PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional)<br>Phantom™ Plus (K082801, Additional)<br>TRYPTIK Ca (K091873, Additional)<br>The predicate devices have not been subject to a design related recall. |
| Description of Device | 4CIS® Marlin ACIF cages are hollow, generally rectangular box<br>shape made either from poly-ether-ether-ketone [PEEK-OPTIMA®<br>LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP®<br>i4R (Evonik Industries, Essen Germany)] or Titanium alloy<br>according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum).<br>The cages are available in a variety of sizes and geometric options to |
| | fit the anatomical needs of a wide variety of patients. |
| | The device is filled with a bone graft material and inserted into the<br>intervertebral body space of the cervical spine through an anterior<br>cervical approach. As the design requirements, this cage design<br>maintains the spacing between two vertebral bones following<br>discectomy until fusion occurs. |
| | Each PEEK cage has three(3) x-ray markers made of tantalum for<br>ease of visualization on the radiographs. |
| | Angled shape for lordotic curve and anatomic shape is available to<br>allow maximum preservation of bony endplate with this system and<br>teeth on the surfaces ensure enough contact with bony endplate,<br>which prevents subsidence of the cage into the vertebral body when<br>the teeth increase the anchoring and prevent slipping or expulsion. |
| Indication for Use | 4CIS® Marlin ACIF Cage System is indicated for use in cervical<br>intervertebral body fusion procedures in skeletally mature patients with<br>degenerative disc disease (DDD) at the levels from C2-C3 disc to the<br>C7-T1 disc. DDD is defined as neck pain of discogenic origin with<br>degeneration of the disc confirmed by patient history and radiographic<br>studies. These patients should have six weeks of non-operative therapy.<br>The 4CIS® Marlin ACIF Cage System is to be used with autogenous<br>bone graft and/or allogenic bone graft comprised of cancellous and/or<br>corticocancellous bone graft, and is to be implanted via an open, anterior<br>approach. It is intended to be used with supplemental spinal fixation<br>systems that have been cleared for use in the cervical spine, such as<br>Anterior Cervical Plate system. |
| Comparison of<br>Technological<br>Characteristics with the<br>Predicate Devices | Indication for Use<br>The subject 4CIS® Marlin ACIF Cage System and all the predicates<br>have similar indications for use statements. |
| | Materials<br>The predicate subject device is composed of the same material as the<br>predicate devices have conforming to recognized industry standards for<br>permanent implants. |
| | Design Features/Functions<br>The subject 4CIS® Marlin ACIF Cage System and cited predicate<br>devices share similar basic design features and functions. |
| | Dimensions<br>The subject 4CIS® Marlin ACIF Cage System is dimensionally similar<br>to cited predicate devices. |
| | Sterilization<br>The subject 4CIS® Marlin ACIF Cage System and cited predicate<br>devices are provided sterile and non-sterile for single use only. |
| | Performance Specification |
| | Mechanical testing confirmed 4CIS® Marlin ACIF Cage System<br>demonstrated equivalent performance to the cited predicate device under<br>the same test conditions. |
| Performance Data | Mechanical testing (static and dynamic compression, static and dynamic<br>torsion, static subsidence and static expulsion) was conducted in<br>accordance with ASTM F2077, and ASTM F2267.<br><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 | Based on the provided performance data, the subject device is<br>substantially equivalent to the referenced predicate devices. |

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