C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE

K121320 · Medyssey Co, Ltd. · ODP · Aug 10, 2012 · Orthopedic

Device Facts

• Record ID: K121320
• Device Name: C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
• Applicant: Medyssey Co, Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Aug 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. C7 Anterior Cervical Intervertebral Fusion 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

Medyssey C7 Anterior Cervical Interbody Fusion Cage is a PEEK interbody spacer designed for cervical spine fusion. Device features trapezoidal shape, central graft window for autogenous bone, and surface ridges to prevent migration. Tantalum markers are embedded for radiographic visualization. Implanted by surgeons via anterior approach; requires supplemental fixation. Device facilitates intervertebral body fusion in patients with degenerative disc disease. No software or electronic components.

Clinical Evidence

Bench testing only. Testing included static compression, static torsion, static compressive shear, dynamic compression, subsidence, and expulsion per ASTM F2077 and ASTM F2267.

Technological Characteristics

Material: PEEK Optima LT1 (Invibio) with tantalum radiographic markers. Design: Trapezoidal interbody spacer with central graft cavity, surface ridges, and anterior threaded instrument hole. Standards: ASTM F2077, ASTM F2267. Non-electronic, mechanical device.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C2-T1) who have failed at least 6 weeks of non-operative treatment.

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

• SpineCraft, LLC ORIO Intervertebral Body Fusion Cages (K090887)
• Custom Spine, Inc. Pathway ACIF (K092904)
• Biomet Spine C-Thru Anterior Spinal System (K092336)

Submission Summary (Full Text)

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K12/320
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# 510(k) Summary

AUG 10 2012

| Company: | Medyssey Co. Ltd.<br>722-3, 4F, Science Tower 4F<br>Dongducheon City<br>Gyeonggido, Korea<br>Tel: [phone]<br>FAX: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael Kvitnitsky<br>Chief Operating Officer<br>Medyssey Co. Ltd<br>8001 N. Lincoln Ave.<br>Suite 401<br>Skokie, IL 60077<br>Tel: [phone]<br>FAX: [phone] |
| Date Prepared: | June 29, 2012 |
| Proprietary Name: | Medyssey C7 Anterior Cervical Interbody Fusion Cage |
| Classification Name: | 87 ODP- Orthosis, intervertebral body fusion device, cervical 21 CFR<br>888.3080, Class II |
| Predicate Device: | · SpineCraft, LLC ORIO Intervertebral Body Fusion Cages (K090887)<br>· Custom Spine, Inc. Pathway ACIF (K092904)<br>· Biomet Spine C-Thru Anterior Spinal System (K092336) |
| Product Description: | The Medyssey C7 Anterior Cervical Interbody Fusion Cage system consists of a<br>series of PEEK (polyetheretherketone) cervical interbody spacers of various<br>footprints and thicknesses. The C7 ACIF cages have ridges on their superior and<br>inferior surfaces to prevent migration, and graft windows to allow for bony fusion.<br>Tantalum markers are incorporated into the devices to allow for radiographic |

### Indications for Use:

The C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. C7 Anterior Cervical Intervertebral Fusion 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.

visualization of the implants.

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K121320
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## Summary of Technological Characteristics:

The Medyssey C7 Anterior Cervical Interbody Fusion Cage System consists of a series of PEEK (polyetheretherketone) Optima LT1 (from Invibio) interbody spacers with tantalum radiographic markers. The C7 ACIF devices are trapezoidal in shape, have a central graft containment cavity, have ridges to resist expulsion and have an anterior threaded hole for instrument. The predicate ORIO ACIF and Pathway ACIF devices are also made from PEEK, with tantalum markers, are trapezoidal in shape, have a central graft containment cavity, ridges to resist expulsion and an anterior threaded hole for instrument attachment.

Medyssey has determined that the minor differences between proposed device and the predicate devices will not impact the safety or effectiveness of the anterior cervical interbody fusion system for its intended use. Analysis has shown that the proposed device is equivalent to the predicate devices.

#### Identification of Legally Marketed Predicate Device:

Documentation was provided, which demonstrates that the subject Medyssey C7 Anterior Cervical Cage is substantially equivalent to the predicate devices the SpineCraft, LLC ORIO Intervertebral Body Fusion Cages (K090887), Custom Spine, Inc. Pathway ACIF (K092904) and Biomet Spine C-Thru Anterior Spinal System (K092336). The proposed Medyssey device has the same indications for use and is manufactured from the same material. The minor differences in the design were evaluated through testing and do not affect the safety and efficacy of the device for its intended use.

#### Brief Discussion of Non-Clinical Tests Submitted:

Numerous tests were performed on the Medyssey Anterior Cervical Interbody Fusion System. The tests performed are recommended by the FDA guidance document for intervertebral body fusion devices, including ASTM F2077 and ASTM F2267. List of Tests is below:

- Static Compression .
- Static Torsion .
- Static Compressive Shear .
- Dynamic Compression �
- Subsidence .
- . Expulsion

### Conclusions from Non-Clinical Tests:

Based on the testing and comparison analysis to the predicate devices provided in this premarket notification submission, Medyssey believes that the subject Medyssey C7 Anterior Cervical Cage System is substantially equivalent to the SpineCraft, LLC ORIO Intervertebral Body Fusion Cages (K090887), Custom Spine, Inc. Pathway ACIF (K092904) and Biomet Spine C-Thru Anterior Spinal System (K092336)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is black and white.

#### Public Health Service

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

AUG 1 0 2012

Medyssey Company Limited % Mr. Michael Kvitnitsky Chief Operating Officer 8001 North Lincoln Avenue, Suite 401 Skokie, Illinois 60077

Re: K121320

Trade/Device Name: Medyssey C7 Anterior Cervical Interbody Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: June 30, 2012 Received: July 23, 2012

Dear Mr. Kvitnitsky:

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

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# Page 2 - Mr. Michael Kvitnitsky

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21-GFR Part 820); and if-applicable, the electronicproduct 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

K121320

510(k) Number (if known):

Device Name: Medyssey C7 Anterior Cervical Interbody Fusion Cages

#### Indications for Use:

The C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. C7 Anterior Cervical Intervertebral Fusion 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.

Prescription Use × (Per 21 CFR 801.109). OR

Over-The-Counter Use (Optional Format 1-2-96)

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Dision of Surgical, Orthopedic, and Restorative Devices

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KI21320 510(k) Number_