INNESIS PEEK CERVICAL CAGE

K132483 · Bk Meditech, Co., Ltd. · ODP · Apr 2, 2014 · Orthopedic

Device Facts

• Record ID: K132483
• Device Name: INNESIS PEEK CERVICAL CAGE
• Applicant: Bk Meditech, Co., Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Apr 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INNESIS PEEK Cervical 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. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical 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

Implant for anterior cervical discectomy and fusion (ACDF); stabilizes cervical spinal column. Device consists of PEEK cage with ridges/teeth to resist migration and cavities for autogenous bone graft; includes titanium alloy spikes and markers for radiological visualization. Used by surgeons in clinical settings. Facilitates intervertebral body fusion; requires supplemental fixation. Benefits patient by providing structural support during fusion process.

Clinical Evidence

Bench testing only. Testing included static/dynamic axial compression, static compression shear, static/dynamic torsion, static subsidence, and expulsion tests per ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F04.25.02.02. Biocompatibility confirmed via material standards.

Technological Characteristics

Materials: PEEK (ASTM F2026) and Titanium Alloy (Ti6Al4V-ELI, ASTM F136). Form factor: Intervertebral cage with ridges/teeth and bone graft cavities. Radiological markers included. Mechanical testing per ASTM F2077 and F2267.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C2-T1). Requires 6 weeks of prior 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

• INNESIS PEEK CAGE(lumbar) (K120464)
• Stryker Spine AVS® AS PEEK Spacer (K120486)
• Southern Spine C-Fuse™ Cervical Intervertebral Body Fusion System (K130948)
• ORIO Intervertebral Body Fusion Cage (K090887)
• Mecta-C (K112862)
• PATHWAY ACIF (K092904)
• C-Thru™ Anterior Spinal System (K092336)
• SYNSTER® CERVICAL CAGE (K111820)
• IMPIX cervical interbody device (K072226)

Submission Summary (Full Text)

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# 510(k) Summary

#### Submitted on behalf of:

Company Name: BK Meditech Co, Ltd Address: 215-5 Yodang-Li, Yanggam-Myun Hwasung-Si, Kyunggi-Do Republic of Korea 445-931 Telephone: [phone] Fax: [phone]

by: Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: [phone] Fax: [phone]

CONTACT PERSON: Elaine Duncan DATE PREPARED: March 3, 2014 TRADE NAME: INNESIS PEEK CERVICAL CAGE COMMON NAME: Intervertebral body fusion device DEVICE CLASSIFICATION Class II CLASSIFICATION NAME: Orthosis, Intervertebral body fusion device, cervical REDUALTION: 888.3080 PRODUCT CODE: ODP

#### INDICATIONS FOR USE:

The INNESIS PEEK Cervical 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. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical 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.

#### DESCRIPTION of the DEVICE:

The INNESIS PEEK Cervical Cage is an implant for the anterior stabilization of the cervical spinal column using an Anterior Cervical Desectorny and Fusion (ACDF) surgery. The INNESIS PEEK Cervical Cages are offered in a variety of heights, footprints and curved shapes. The INNESIS PEEK Cervical Cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The INNESIS PEEK Cervical Cage includes spikes and marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage

#### SUBSTANTIALLY EQUIVALENCE DEMONSTRATED BY:

The subject and predicate devices are substantially equivalent in the areas of materials, design, indications for use and operational principles. Based on the comparison between the subject

# APR 0 2 2014

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and predicate devices, BK MEDITECH Co., Ltd. believes that the INNESIS PEEK Cervical Cages are substantially equivalent (as fully detailed in the submission) to predicate devices which include the following devices:

| Company Name | Device Tradename | 510(k)<br>Number |
|---------------------------|----------------------------------------------------------------------|------------------|
| BK MEDITECH Co., Ltd | INNESIS PEEK CAGE(lumbar) | K120464 |
| Stryker Spine | Stryker Spine AVS® AS PEEK Spacer | K120486 |
| Southern Spine, LLC | Southern Spine C-Fuse™ Cervical<br>Intervertebral Body Fusion System | K130948 |
| SpineCraft, LLC | ORIO Intervertebral Body Fusion Cage by | K090887 |
| Medacta International, SA | Mecta-C | K112862 |
| Custom Spine | PATHWAY ACIF | K092904 |
| Biomet Spine | C-Thru™ Anterior Spinal System | K092336 |
| BM Korea | SYNSTER® CERVICAL CAGE | K111820 |
| Medicrea Technologies | IMPIX cervical interbody device | K072226 |

#### SUMMARY of TESTING:

Testing results are for the following:

- Static and dynamic axial compression test, conducted in accordance with ASTM F2077-03
- Static compression shear test, conducted in accordance with ASTM F2077-03
- Static and dynamic torsion test, conducted in accordance with ASTM F2077-03
- Static subsidence test, conducted in accordance with ASTM F2267-04
- Expulsion test, conducted in accordance with ASTM Draft Standard F04.25.02.02.

The material of the INNESIS PEEK Cervical Cage (permanent implant- long term) is PEEK (Polyetheretherketone, ASTM F2026) and Titanium Alloy (Ti6Al4V-ELI, ASTM F136). These materials are both recognized as suitable biomaterials for this intended use and predicate devices have previously been cleared by FDA for this same intended use. Endotoxin testing has demonstrated that the process does not introduce endotoxins as a bi-product of the manufacturing and cleaning process.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

April 2, 2014

BK Meditech Co., Ltd. % Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K132483

Trade/Device Name: INNESIS PEEK Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 3, 2014 Received: March 4, 2014

Dear Ms. Duncan:

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 11 (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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 -Elaine Duncan, MS.ME. RAC

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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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) K132483

Device Name INNESIS PEEK CERVICAL CAGE

#### Indications for Use (Describe)

The INNESIS PEEK Cervical 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-TI). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are ior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

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

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