INTESS CERVICAL CAGE SYSTEM

K133815 · Kalitec Direct, LLC · ODP · Apr 16, 2014 · Orthopedic

Device Facts

• Record ID: K133815
• Device Name: INTESS CERVICAL CAGE SYSTEM
• Applicant: Kalitec Direct, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Apr 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

Device Story

INTESS™ Cervical Cage is an intervertebral body fusion implant for cervical column stabilization. Device features graft windows for bony integration and ridges on superior/inferior surfaces for stability; includes integrated X-ray markers for surgical visualization. Implanted by surgeons via open, anterior approach to maintain disc space until fusion occurs. Used in conjunction with supplemental internal fixation systems and autogenous bone graft. Benefits patients by providing structural support during the spinal fusion process.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing, including static and dynamic compression and torsion (ASTM F2077) and subsidence testing (ASTM F2267).

Technological Characteristics

Materials: Zeniva ZA500 PEEK (ASTM F2026) and unalloyed tantalum (ASTM F560). Design: Intervertebral cage with graft windows and surface ridges. Integrated X-ray markers for visualization. Mechanical testing per ASTM F2077 and ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) at one level (C2-T1) requiring anterior interbody spinal fusion. Requires six weeks of prior non-operative treatment. Used with supplemental internal fixation and autogenous bone graft.

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

• Spinal Elements, Crystal Cervical Cage (K073351)
• Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)
• LDR Spine Cervical Interbody Fusion System (K091088)
• Daytona Anterior Cervical Cage System (K110733)

Submission Summary (Full Text)

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### APR 1 6 2014

### 510(k) Summary for the INTESS™ Cervical Cage

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the INTESS™ Cervical Cage

#### 1. GENERAL INFORMATION

| Date Prepared: | April 10, 2014 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | INTESS™ Cervical Cage |
| Common Name: | intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device - cervical |
| Class: | II |
| Product Code: | ODP |
| CFR section: | 21 CFR section 888.3080 |
| Device panel: | Orthopedic |
| Legally Marketed | Spinal Elements, Crystal Cervical Cage (K073351) |
| Predicate Device: | Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)<br>LDR Spine Cervical Interbody Fusion System (K091088)<br>Daytona Anterior Cervical Cage System (K110733) |
| Submitter: | Kalitec Direct, LLC<br>618 E. South Street, Suite 500<br>Orlando, FL 32801<br>W [phone] |
| Contact: | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-mail: [e-mail] |

#### 2. DEVICE DESCRIPTION

The INTESS™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.

#### Materials:

Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

#### Function:

Maintain adequate disc space until fusion occurs.

#### SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.

The INTESS™ Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

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#### 4. INTENDED USE

The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

#### 5. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

- . Static and dynamic compression per ASTM F2077
- . Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267 .

The results of this testing indicate that the INTESS™ Cervical Cage is equivalent to predicate devices.

#### 6. CLINICAL TEST SUMMARY

No clinical studies were performed

### 7. CONCLUSIONS NONCLINICAL AND CLINICAL

Kalitec Direct, LLC considers the INTESS™ Cervical Cage to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 16, 2014

Kalitec Direct, LLC % The OrthoMedix Group, Incorporated Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K133815

Trade/Device Name: INTESS™ Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 21, 2014 Received: January 23, 2014

Dear Mr. Webb:

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

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#### Page 2 - Mr. J.D. Webb

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/Safetv/ReportalProblem/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.

Sincercly 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

#### K133815

#### Device Name

### INTESS™ Cervical Cage

#### Indications for Use (Describe)

The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-TI). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

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

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🇿 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)

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