MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™

K172212 · Ctl Medical Corporation · ODP · Jan 9, 2018 · Orthopedic

Device Facts

• Record ID: K172212
• Device Name: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
• Applicant: Ctl Medical Corporation
• Product Code: ODP · Orthopedic
• Decision Date: Jan 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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 radios. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Story

Interbody fusion cage system; maintains cervical intervertebral spacing; facilitates fusion at C3-C7 levels. Used in surgical setting by orthopedic/neurosurgeons. Implanted during anterior cervical discectomy and fusion (ACDF) procedures. Requires concurrent use of supplemental fixation systems. Provides structural support for bone graft; promotes spinal fusion. Available in various sizes/configurations to match patient anatomy.

Clinical Evidence

Bench testing only. Static and dynamic axial compression testing (ASTM F2077) and subsidence testing (ASTM F2267) performed. Results met all acceptance criteria established for predicate devices.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 or VESTAKEEP i-Grade PEEK, titanium alloy, and titanium alloy marker pins. Dimensions: range within predicate device specifications. Testing standards: ASTM F2077 (static/dynamic axial compression), ASTM F2267 (subsidence).

Indications for Use

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

• MATISSE Anterior Cervical Interbody Fusion Cage System (K121569)
• MATISSE Anterior Cervical Interbody Fusion Cage System (K162682)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

CTL Medical Corporation % Paul Speidel Senior Regulatory/Quality Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

January 9, 2018

# Re: K172212

Trade/Device Name: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 6, 2017 Received: December 12, 2017

Dear Mr. Speidel:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Katherine D. Kavlock -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) K172212

#### Device Name

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKTM

#### Indications for Use (Describe)

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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 radios. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) SUMMARY

# CTL Medical Corporation's MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™

| Submitter | CTL Medical Corporation<br>Andrea Wilcox<br>4550 Excel Parkway Suite 300<br>Addison, TX 75001<br><br>Phone: [phone]<br>Fax: [phone] |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barry Sands<br>RQMIS, Inc.<br>110 Haverhill Road, Suite 526<br>Amesbury, MA 01913<br>Phone: [phone] |

Date Prepared: December 6, 2017

| Name of Device | MATISSE Anterior Cervical<br>Interbody Fusion Cage System,<br>Ti-PEEK™ |
|--------------------------|-----------------------------------------------------------------------------------------------|
| Name/Address of Sponsor: | CTL Medical Corporation<br>Andrea Wilcox<br>4550 Excel Parkway Suite 300<br>Addison, TX 75001 |

#### Common or Usual Name

Intervertebral Body Fusion Device

#### Classification Name

Intervertebral Body Fusion Device, Cervical (Product Code ODP)

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#### Class

Class II

### Classification Number

21 CFR 888.3080

Predicate Devices

Primary Predicate: K121569, MATISSE Anterior Cervical Interbody Fusion Cage System; and

# Additional Predicate: K162682 MATISSE Anterior Cervical Interbody Fusion Cage System.

#### Device Description

#### Indications for Use:

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

#### Device Description:

The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is intended for use as an interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of either PEEK-OPTIMA LT1 (Invibio) or VESTAKEEP i-Grade (Evoniks) PEEK with titanium alloy and titanium alloy marker pins.

#### Technological Characteristics

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The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ consists of OPTIMA LT1 (Invibio) or VESTAKEEP i-Grade (Evoniks) PEEK with titanium alloy and marker pins made of titanium alloy, both of which are identical to its predicate device with the exception of titanium alloy marker pins. All of the heights, lengths, and widths are within the range covered by its predicate device.

#### Performance Data

The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ device underwent testing according to ASTM F2077, specifically static and dynamic axial compression testing; and subsidence testing according to ASTM F2267. The results met all acceptance criteria established previously for the predicate devices and demonstrate that the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ does not raise concerns regarding safety and effectiveness.

#### Conclusion

The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is as safe and effective as the predicate MATISSE Anterior Cervical Interbody Fusion Cage System, Titanium and PEEK (K162682 and K121569). The MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ and its predicate devices raise no new issues of safety or effectiveness. Thus, the MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is substantially equivalent.