AnyPlus® Cervical PEEK Cage System

K153517 · GS Medical Co., Ltd. · ODP · Jun 24, 2016 · Orthopedic

Device Facts

• Record ID: K153517
• Device Name: AnyPlus® Cervical PEEK Cage System
• Applicant: GS Medical Co., Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Jun 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AnyPlus® Cervical PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Intervertebral body fusion device; restores intervertebral space height after disc resection. Implants feature open architecture for autograft bone packing; available in various heights and lordotic configurations. Used in cervical spine (C3-C7) by surgeons; requires supplemental fixation. Radiolucent PEEK body with Tantalum markers allows X-ray visualization for placement verification. Non-sterile, single-use device. Provides interbody stabilization to facilitate fusion; benefits patients by addressing discogenic pain associated with DDD.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included static and dynamic axial compression, compression-shear, torsion, expulsion, and subsidence testing per ASTM 2077 and ASTM F2267. Results were equivalent to or higher than predicate devices.

Technological Characteristics

Materials: PEEK Optima LT1 body, Tantalum X-ray markers. Design: Open architecture, various heights/lordotic configurations. Standards: ASTM F2077-11, ASTM F2267-04. Non-sterile, single-use. No software or electronics.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with radicular symptoms at one level, following at least 6 weeks of failed non-operative treatment. Requires use with autograft bone and supplemental fixation.

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

• US Spine Phantom Cervical Cage (K082801)
• SpineArt Tryptik Cervical Cage (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

June 24, 2016

GS Medical Company, Ltd. % Mr. Barry E. Sands President RQMIS, Incorporated 29 Water Street, Suite 305 Newburyport, Massachusetts 01950

Re: K153517

Trade/Device Name: AnyPlus® Cervical PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 26, 2016 Received: May 27, 2016

Dear Mr. Sands:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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,

# Lori A. Wiggins -S

for

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) K153517

Device Name AnyPlus® Cervical PEEK Cage System

#### Indications for Use (Describe)

The AnyPlus® Cervical PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: larger;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) SUMMARY

### GS Medical Co., Ltd.

# AnyPlus® Cervical PEEK Cage System

| Manufacturer: | GS Medical Co., Ltd.<br>90, Osongsaengmyeong 4-ro<br>Osong-eup<br>Cheongwon-gun<br>Chungcheongbuk-do<br>363-951 Korea |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 20, 2016 |
| Submitted by: | GS Medical Co., Ltd |
| Company Contact | Marcin Niemiec |
| US Agent Information<br>Official Correspondent | RQMIS Inc.<br>Mr. Barry E. Sands<br>110 Haverhill Road, Suite 526<br>Amesbury, MA 01913<br>Ph: 978-358-7307<br>www.rqmis.com |
| Proprietary Name: | AnyPlus® Cervical PEEK Cage System |
| Performance standards: | The AnyPlus® Cervical PEEK Cage System was non-clinically tested<br>according to the ASTM 2077-11 and ASTM F2267-04 performance<br>standards. |
| Regulation:<br>Common/Usual Name:<br>Classification name:<br>Review Panel:<br>Product Code:<br>Device Class: | 21 CFR 888.3080<br>Cervical Spinal Fusion Device, IBF Device<br>Intervertebral body fusion device – Cervical<br>Orthopedic<br>ODP<br>Class II |
| Substantial Equivalence: | Substantial equivalence for the AnyPlus® Cervical PEEK Cage System is<br>based on its similarities in indications for use, design features,<br>operational principles and material composition when compared to the<br>predicate devices. |
| Predicate Devices: | <ul><li>K082801 US Spine Phantom Cervical Cage (primary)</li><li>K091873 SpineArt Tryptik Cervical Cage (secondary)</li></ul> |
| | The subject device is substantially equivalent to similar previously<br>cleared devices. |

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| Device Description: | The AnyPlus® Cervical PEEK Cage System is designed for restoring the<br>height of the intervertebral space after resection of the disc. AnyPlus®<br>Cervical PEEK Cage System consists of implants available in various<br>heights and lordotic configurations with an open architecture to accept<br>packing of bone graft material. The intervertebral body fusion devices<br>are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the<br>X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical<br>PEEK Cage System are radiolucent allowing X-ray visualization to verify<br>device placement. AnyPlus® Cervical PEEK Cage System is supplied non-<br>sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage<br>System is designed for interbody stabilization of the cervical spine. |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The AnyPlus® Cervical PEEK Cage System is indicated for use in<br>skeletally mature patients with degenerative disc disease (DDD) of the<br>cervical spine with accompanying radicular symptoms at one disc level.<br>DDD is defined as discogenic pain with degeneration of the disc<br>confirmed by patient history and radiographic studies. AnyPlus®<br>Cervical PEEK cages are used to facilitate intervertebral body fusion in<br>the cervical spine at the C3 to C7 disc levels using autograft bone.<br>AnyPlus® Cervical PEEK cages are to be used with supplemental fixation.<br>Patients should have at least six (6) weeks of non-operative treatment<br>prior to treatment with an intervertebral cage. |
| Summary of Technological<br>Characteristics | The AnyPlus® Cervical PEEK cages are designed for restoring the height<br>of the intervertebral space after resection of the disc. The AnyPlus®<br>Cervical PEEK cages consist of implants available in various heights and<br>lordotic configurations with an open architecture to accept packing of<br>bone graft material. The implants are made of polyether-ether-ketone<br>(PEEK) body with the x-ray markers made of Tantalum. The intended<br>use, technological characteristics, mode of action and materials of<br>construction are the same as those of the referenced predicate devices |
| Non-Clinical Testing | The AnyPlus® Cervical PEEK cages were tested according to the ASTM<br>2077, specifically, Static and Dynamic Axial Compression, Static and<br>Dynamic Compression-Shear Testing, Static and Dynamic Torsion<br>Testing Expulsion Testing and Static Subsidence testing under Axial<br>Compression, per ASTM 2267. All performance test results were<br>equivalent to or higher than a legally marketed predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The AnyPlus® Cervical PEEK cages have the same intended use and<br>similar indications, principles of operation, and technological<br>characteristics as the predicate devices. The minor differences in the<br>designs do not raise any new questions of safety or effectiveness.<br>Performance data demonstrates that the AnyPlus® Cervical PEEK cages<br>are as safe and effective as the predicate devices. Thus, the AnyPlus®<br>Cervical PEEK cages are substantially equivalent to the predicate<br>devices. |