INTERFUSE T INVERTEBRAL BODY FUSION DEVICE

K110226 · Vertebral Technologies, Inc. · MAX · May 27, 2011 · Orthopedic

Device Facts

• Record ID: K110226
• Device Name: INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
• Applicant: Vertebral Technologies, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterFuse® T - 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 T 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 T 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

InterFuse T is an intervertebral body fusion device composed of PEEK-OPTIMA polymer segments; segments feature integral rails/slots for assembly and tantalum beads for radiographic visualization. Surgeon assembles segments in situ; middle segment locks adjacent pieces. Device includes vertical slots for autogenous bone graft packing to facilitate fusion. Available in various heights and AP lengths to accommodate disc geometry. Used in spinal fusion procedures by surgeons; requires supplemental internal fixation. Benefits patient by providing structural support and promoting bone growth in DDD cases.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via static and dynamic compression, compression shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing.

Technological Characteristics

Material: PEEK-OPTIMA (Polyetheretherketone) with embedded tantalum beads. Design: Modular segments with rail/slot engagement and ramp locks. Dimensions: 8-14 mm heights, 20-24 mm AP lengths. Energy: None (mechanical implant). Sterilization: Gamma irradiation. Standards: ASTM F2077 (compression/shear), ASTM F2267 (subsidence).

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. Requires at least 6 months of failed non-operative treatment. May be used in patients with prior non-fusion surgery at the involved level(s). Must be used with autogenous bone graft and supplemental internal spinal 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

• InterFuse® T Intervertebral Body Fusion Device (K102277)

Submission Summary (Full Text)

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K110226

## 3. 510(k) SUMMARY

MAY 2 7 2011

510(k) SUMMARY [as required by section 807.92(c)]

| 510(k) Owner's Name: | Vertebral Technologies, Inc. | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------|--|
| Address: | 5909 Baker Road, Suite 550<br>Minnetonka, MN 55345 | |
| Phone/Fax/Email: | Office - Direct: [phone]<br>Company Main Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] | |
| Name of Contact Person: | Suresh Ghai, Ph.D.<br>VP, Quality and Regulatory Affairs | |
| Date prepared: | 25th January, 2011 | |
| Trade or Proprietary Name: | InterFuse®T - Intervertebral Body Fusion Device | |
| Common or Usual Name: | Intervertebral Body Fusion Device | |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumba<br>21 CFR § 888.3080<br>Product code: MAX<br>Device Class: II | |

3.1 LEGALLY MARKETED DEVICE TO WHICH YOUR FIRM IS CLAIMING EQUIVALENCE The modified InterFuse® T - Intervertebral Body Fusion Device is substantially equivalent in performance, indication, design and material to VTI's own InterFuse® T Intervertebral Body Fusion Device cleared under Premarket notification # K102277.

#### 3.2 DEVICE DESCRIPTION

VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Polyetheretherketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-rav. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment (B) is installed. 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 (8, 10, 12 and 14 mm) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. InterFuse T device will be available in two anterior - posterior (AP) lengths of 20 mm and 24 mm. The middle segment (B) comes in two widths (9 mm or 10 mm).

Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

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#### 3.3 INTENDED USE OF THE DEVICE

The InterFuse® T - 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 T 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 T 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.

#### 3.4 TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

The modified InterFuse® T - Intervertebral Body Fusion Device (current submission) is substantially equivalent in performance, indication, design and materials to InterFuse® T Intervertebral Body Fusion Device from Vertebral Technologies, Inc., cleared under 510(k) premarket notification # K102277.

#### 3.5 SUMMARY AND CONCLUSIONS FROM THE NONCLINICAL TESTS SUBMITTED

The substantial equivalence is supported by bench testing comparing the modified InterFuse® T Intervertebral Body Fusion Device to the predicate un-modified device (K102277).

The basic design of the device has not changed from the 510(k) cleared device (K102277). Devices with a new AP length (i.e. 20 mm) are being added in this submission.

There is no change to the materials of construction of the device, manufacturing process, packaging materials, packaging configuration, sealing parameters (and sealing equipment), sterilization process and sterility assurance level. The shelf-life of the modified device has also not changed.

The performance of the modified device (InterFuse T) was tested, post gamma irradiation sterilization as detailed below:

- Static and Dynamic Compression; Static and Dynamic Compression Shear per ASTM F2077 .
- Subsidence per ASTM F2267 .
- Expulsion testing .

Substantial equivalence comparison between the modified InterFuse T and the predicate device is given in section 10.

The detailed performance results are given in section 11.

On the basis of performance data it is concluded that the modified device (InterFuse T -Intervertebral Body Fusion Device) is substantially equivalent to the unmodified InterFuse T device (K102277).

Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

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

Vertebral Technologies, Inc. % Suresh Ghai, Ph.D. VP, Quality & Regulatory Affairs 5909 Baker Road, Suite 550 Minnetonka, Minnesota 55345

MAY 2 7 2011

Re: K110226

Trade/Device Name: InterFuse T Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 03, 2011 Received: May 05, 2011

Dear Dr. Ghai:

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

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Page 2 - Suresh Ghai, Ph.D.

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric S. Keith

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

Enclosure

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### 2. STATEMENT OF INDICATION FOR USE

# Indication for Use

KIIO226 510(k) Number (if known): Device Name: InterFuse® T - Intervertebral Body Fusion Device

### Indications for Use:

The InterFuse® T - 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 at the involved level(s). The InterFuse T 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 T 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Or

vision of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K110226

Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

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