IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

K131951 · X-Spine Systems, Inc. · OVE · Aug 14, 2013 · Orthopedic

Device Facts

• Record ID: K131951
• Device Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Applicant: X-Spine Systems, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Aug 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of nonoperative treatment prior to treatment with a cervical intervertebral fusion device.

Device Story

Irix-C is a stand-alone intervertebral fusion device designed to restore biomechanical height and facilitate fusion in the cervical spine. Used during anterior discectomy procedures, the device is implanted by a surgeon via an open, anterior approach. The box-shaped implant is packed with autogenous bone graft to promote fusion and secured using integrated titanium alloy bone screws. By stabilizing the vertebral segment, the device aims to alleviate pain associated with degenerative disc disease. It is provided non-sterile and requires steam autoclave sterilization by the healthcare facility prior to use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including static and dynamic compression and torsion (ASTM F2077), load-induced subsidence (ASTM F2267), and internal testing for expulsion, screw back-out, and dissociation.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V, ASTM F136) and PEEK Optima LT1 (ASTM F2026). Optional plasma coating with commercially pure titanium (ASTM F1580). Form factor: Box-shaped implant with superior/inferior teeth and integrated bone screws. Sterilization: Steam autoclave (user-performed).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain confirmed by history/radiography) requiring single-level spinal fusion (C3-T1). Requires 6 weeks prior nonoperative treatment. Contraindicated in patients without skeletal maturity.

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

• Globus Medical, Inc. - COALITION Spacer (K083389)
• Centinel Spine. Inc. - STALIF-C (K120819)
• X-spine Systems, Inc. - Calix PC Spinal Implant System (K112036)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(k) Summary

### ADMINISTRATIVE INFORMATION

Manufacturer Name:

X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342

Telephone [phone] FAX [phone]

Official Contact:

David Kirschman, M.D. Chief Medical Officer

June 26, 2013

**AUG** 1 4 2013

Date Prepared:

DEVICE NAME

Trade/Proprietary Name: Common Name: Device Class: Regulation Number: Product Code: Classification Name:

Irix-C™ Cervical Integrated Fusion System Intervertebral body fusion device Class II \$888.3080 OVE Intervertebral Fusion Device with Integrated Fixation, Cervical

### ESTABLISHMENT REGISTRATION NUMBER

The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

## INDICATIONS FOR USE

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of nonoperative treatment prior to treatment with a cervical intervertebral fusion device.

### DEVICE DESCRIPTION

The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the Irix-C implant is manufactured from both titanium alloy (Ti6Al4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.

{1}------------------------------------------------

The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.

## EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Irix-C Cervical Integrated Fusion System is substantially equivalent to predicate devices based on a comparison including the following characteristics:

- . FDA Product Code
- Indications for Use .
- . Surgical Approach
- . Anatomical Region
- . Implant Materials
- . Product Dimensions
- . Mechanical Performance

## PREDICATE DEVICES

- . Globus Medical, Inc. - COALITION Spacer (K083389)
- . Centinel Spine. Inc. - STALIF-C (K120819)
- . X-spine Systems, Inc. - Calix PC Spinal Implant System (K112036)

## PERFORMANCE DATA

The implant components were tested using the following standards:

ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices

- Static and Dynamic Compression .
- Static and Dynamic Torsion .

ASTM F2267 - Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression

In addition to the above standard testing, expulsion, screw back out and dissociation tests were performed as part of this submission. There are no cited standard for these tests.

The mechanical testing results indicate that the Irix-C Cervical Integrated Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.

{2}------------------------------------------------

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

August 14, 2013

X-Spine Systems, Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K131951

Trade/Device Name: Irix-C Cervical Integrated Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: June 26, 2013 Received: June 27, 2013

Dear Dr. Kirschman:

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

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

{3}------------------------------------------------

Page 2 - David Kirschman, M.D.

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" (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/ResourcesforYou/Industry/dcfault.htm.

Sincerely yours,

# Erinil. Keith

# For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Premarket Notification

Irix-C Cervical Integrated Fusion System

#### Indications for Use

510(k) Number (if known): K131951

Device Name: Irix-C™ Cervical Integrated Fusion System

Indications for Use:

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of nonoperative treatment prior to treatment with a cervical intervertebral fusion device.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices