BN LUMBAR CAGE SYSTEM

K140564 · Medyssey USA, Inc. · MAX · Jun 5, 2014 · Orthopedic

Device Facts

• Record ID: K140564
• Device Name: BN LUMBAR CAGE SYSTEM
• Applicant: Medyssey USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BN Cage® is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Device Story

Medyssey BN Cage is an intervertebral body fusion device providing mechanical support during biologic fusion. Implants are PEEK Optima LT1 with Tantalum radiopaque markers; available in 105 sizes, 0 or 8-degree lordosis, 9mm width, 22-32mm length, and 8-15mm height. Used by surgeons in clinical settings for spinal fusion procedures. Device requires supplemental fixation and autograft bone. Mechanical support facilitates spinal stability in patients with DDD.

Clinical Evidence

Bench testing only. Mechanical testing included static axial compression, static compression shear, static torsion, subsidence, and dynamic axial compression per ASTM F2077 and ASTM F2267. Results confirmed performance equal to or greater than predicate devices.

Technological Characteristics

Material: PEEK Optima LT1 (implant), Tantalum (markers per ASTM F560). Principle: Intervertebral body fusion support. Dimensions: 9mm width, 22-32mm length, 8-15mm height, 0 or 8-degree lordosis. Mechanical testing standards: ASTM F2077, ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade I spondylolisthesis or retrolisthesis. Requires 6 months prior non-operative treatment. Must be used with supplemental fixation and autograft bone.

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

• Medyssey LP Cage (K110067)
• Stryker AVS Spacer (K093704)

Submission Summary (Full Text)

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# 510(k) Summary

JUN 0 5 2014

Company: Medyssey Co. Ltd. 148, Sandan-Ro 68 Beon-Gil Uijeonbu-City Gyeonggido, Korea Tel: [phone] FAX: [phone]

Contact: John Kuczynski Vice President of R&D and RA Medyssey USA, Inc. 1550 E. Higgins Road Suite 123 Elk Grove Village, IL 60007 Tel: [phone] FAX: [phone]

Date Prepared: February 3, 2014

Proprietary Name: Medyssey BN Cage

Classification Name: 87 MAX- Orthosis, intervertebral body fusion device, 21 CFR 888.3080, Class II

Predicate Device: The predicate devices include the Medyssey LP Cage (K110067) and the Stryker AVS Spacer (K093704).

#### Product Description:

The Medyssey BN Cage is designed to provide mechanical support while biologic fusion takes place. The system consists of 105 sizes of implants in zero degrees and 8 degrees of lordosis. The lordotic angles are bi-convex to accommodate the convexity of the vertebral body above and below the implants are 9mm wide. Implant lengths range from 22-32mm and the height range from 8-15mm.

The Medyssey BN Cage implants are composed of PEEK Optima LT1 from Invibio. The radiopaque markers are made from Tantalum per ASTM F560.

#### Indications for Use:

The BN Cage® is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

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

Mechanical testing of the BN Cage included static axial compression, static compression shear, static torsion, subsidence and dynamic axial compression per ASTM F2077 and ASTM F2267. Test results demonstrated that the BN Cage is equal to or greater than the same test parameters of the predicate devices.

### Conclusions from Non-Clinical Tests:

Medyssey concludes that the BN Cage is substantially equivalent to the predicate devices. The areas where the BN Cage is substantially equivalent to the predicate devices include:

- . The Indications for Use are exactly the same as the Medyssey LP Cage.
- . The material is exactly the same as the Stryker AVS Cage.
- The dimensions are substantially equivalent to the predicate devices.
- The mechanical test results demonstrate the BN Cage is substantially equivalent to the . predicate devices.
- . The proposed surgical approach is the same as the predicate devices.

Medyssey concludes that any minor differences raise no new questions of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a person with their arms outstretched.

#### Public Health Service

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

June 5, 2014

Medyssey Company Limited % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Mvers, Florida 33905

Re: K140564

Trade/Device Name: BN Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 4, 2014 Received: March 5, 2014

Dear Dr. Jansen:

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 actives, good manarationing prossions of 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 it may be sucject to additions, 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 that I Dri has intatutes and regulations administered by other Federal agencies. You must of any I oderal battle registements, including, but not limited to: registration and listing (21 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 de rice-relation actions overses (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Rich Jansen, Pharm.D.

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 requlation 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/Reportal?roblem/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,

# Ronald P. Jean -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) K140564

Device Name BN Cage

## Indications for Use (Describe)

The BN Cage is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Anton E. Dmitriev, PhD

# Division of Orthopedic Devices

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