INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE

K080673 · Vertebral Technologies, Inc. · MAX · Jun 10, 2008 · Orthopedic

Device Facts

• Record ID: K080673
• Device Name: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Vertebral Technologies, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterFuse™ Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

Device Story

Modular intervertebral body fusion device; composed of PEEK segments with embedded tantalum beads for radiographic visualization. Segments feature integral rails/slots for assembly within the disc space; vertical slots allow for autogenous bone graft packing to facilitate fusion. Device implanted by surgeons during spinal fusion procedures; provides structural support and maintains disc space height. Modular design allows 3-6 segments per patient; available in various heights and lordotic angles. Used in conjunction with supplemental internal spinal fixation systems. Benefits include stabilization of the vertebral segment and promotion of bone growth for fusion.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including load deflection, cyclic fatigue resistance, material consistency, and stability testing. Cadaver evaluations verified surgical technique and instrument performance. Biocompatibility verified per ISO 10993; sterility verified per EN550.

Technological Characteristics

Materials: PEEK polymer, tantalum (radiopaque markers). Modular design with rail/slot assembly. Dimensions: 4 heights, 2 anterior-posterior sizes, flat and lordotic configurations. Biocompatibility: ISO 10993. Sterilization: EN550. Energy source: None (mechanical).

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, who have failed at least 6 months of non-operative treatment. May be used in patients with prior non-fusion surgery at the involved level(s).

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

• Zimmer / Spine Tech; BAK Vista (P95002)
• Synthes Spine; SynFix™-LR (K072253)
• RSB Spine; InterPlate (K071922)

Submission Summary (Full Text)

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

Page 1 of 3

# 510(k) Summary

JUN 1 0 2008

# Vertebral Technologies, Inc.

# InterFuse™ Intervertebral Body Fusion Device

510(k) Notification_ KO 806 73

#### MANUFACTURER INFORMATION

- Name & Vertebral Technologies, Inc. (VTI) Address: 5909 Baker Road, Suite 550 Minnetonka, MN 55345 USA
Summary Prepared: March 7, 2008

Contact: Philip B. Jarvi Vice President, Q.A. / Regulatory Affairs 952-912-5400 phone [phone] fax

#### DEVICE INFORMATION

Trade Name: InterFuse™ Intervertebral Body Fusion Device (IFD)

Classification Name: 21CFR 888.3080 - Intervertebral Fusion Device with Bone Graft, Lumbar

Product Code: MAX

Common / Usual Name: Intervertebral Body Fusion Device

Substantial equivalence: The Vertebral Technologies, Inc (VTI) InterFuse™

Intervertebral Body Fusion Device is substantially equivalent to FDA approved predicate devices with regard to materials, technological characteristics, indications for use and surgical techniques. These predicate devices are:

Zimmer / Spine Tech; BAK Vista - (P95002) Synthes Spine; SynFix™-LR - (K072253) RSB Spine; InterPlate - (K071922)

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

080673 ge 20f 3

## Device Description:

VTI's IFD device is made of PEEK, a polymer with a history of use in interbody fusion device designs, and which has modulus similar to bonc. Each segment of the device has embedded metal beads (tantalum) that aid in visualizing the implanted device under x-ray and to aid in position retention when assembled in the disc space. Each segment has an integral rail and / or slot which slides through the rail or slot in the adjacent segment to complete the device. Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and six segments for optimum coverage of the vertebral end plate. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights and two anterior-posterior dimensions to fit a range of potential disc spaces. The device will also be produced in flat and angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.

## Intended Use:

The InterFuse™ Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

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

KOYOG

Substantial Equivalence: The VTI InterFuse™ IFD is substantially equivalent to FDA approved predicate devices with regard to indications for use, materials, technological characteristics and surgical techniques. The InterFuse™ IFD offers no additional risks to the patient and the materials and manufacturing methods add no new or additional safety concerns. The InterFuse™ IFD, as well as the predicates, is submitted without clinical information. The substantially equivalent predicate devices are:

> Zimmer / Spine Tech: BAK Vista - (P95002) Synthes Spine; SynFix™-LR - (K072253) RSB Spine; InterPlate - (K071922)

Testing: The InterFuse™ Implant has been developed, verified and validated in compliance with a comprehensive design process. The corresponding Bench Testing has been accomplished according to a Master Test Plan for the device. The test plan shows the required test, the source of the requirement, the protocol and the report. If the method is from a standard, the voluntary standard is referenced.

The bench testing has demonstrated the physical attributes and durability of the InterFuse™ IFD by load deflection, cyclic fatigue resistance, material consistency and stability and processing control. Cadaver testing has verified the surgical technique and instrument performance. Bench testing and cadaver evaluations have also verified the desired performance requirements of device stability, as defined by the resistance of the device to expulsion from the disc space or disassembly in the joint space and resistance to subsidence.

The InterFuse™ IFD also demonstrated that it meets internationally recognized standards for biocompatibility (ISO 10993) and sterility (EN550).

Clinical testing was not used to determine substantial equivalence.

Summary: Based on the evidence of substantial equivalence the InterFuse™ IFD is considered to be safe and effective and will perform as well or better than the referenced predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 0 2008

Vertebral Technologies, Incorporated % Philip B. Jarvi and Associates Mr. Philip B. Jarvi Vice President, Quality Assurance/Regulatory Affairs 14289 Yellowpine Andover, Minnesota 55304

Re: K080673

> Trade/Device Name: InterFuse" Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: March 07, 2008 Received: March 12, 2008

Dear Mr. Jarvi:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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

Page 2 - Mr. Philip B. Jarvi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: InterFuse™ Intervertebral Body Fusion Device

Indications for Use:

The InterFuse™ Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

Prescription Use Yes Over-The-Counter Use No AND/OR (Part 21 CFR 801 Subpart D) (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)

Neil R. Ogle for mem

Sion of General, Restorative, and Neurological Devices

510(k) Number: K080673

Page 1 of 1