INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076

K093675 · Vertebral Technologies, Inc. · MAX · Dec 23, 2009 · Orthopedic

Device Facts

• Record ID: K093675
• Device Name: INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
• Applicant: Vertebral Technologies, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• 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 1 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

InterFuse Intervertebral Body Fusion Device is a modular spinal implant system. Device consists of multiple PEEK segments with embedded tantalum beads for radiographic visualization. Segments feature integral rails and slots for assembly within the disc space; segments lock together to form a single construct. Implanted by surgeons during spinal fusion procedures to provide structural support for bone graft. Modular design allows customization of height and lordotic angle to match patient anatomy. Used in conjunction with supplemental internal spinal fixation systems. Benefits include stabilization of the intervertebral space to facilitate fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Accelerated aging performed at 55°C per ASTM F1960-07. Performance testing conducted per ASTM F2077-03. Biocompatibility verified via cytotoxicity testing per ISO 10993. No clinical data presented.

Technological Characteristics

Materials: PEEK (Poly ether ether ketone) and tantalum beads. Modular design with interlocking rails/slots. Heights: 8, 10, 12, 14 mm. Lordotic angles: 5 options. Standards: ASTM F1960-07 (accelerated aging), ASTM F2077-03 (mechanical testing), ISO 10993 (biocompatibility).

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 1 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.

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® Intervertebral Body Fusion Device (K080673)

Submission Summary (Full Text)

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A final order reclassifying shortwave diathermy (SWD) intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here: https://www.federalregister.gov/documents/2015/10/13/2015-

25923/physical-medicine-devices-reclassification-of-shortwavediathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K093675 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure embracing a bird, which is the department's emblem. The image is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

DEC 2 3 2009

Re: K093675

Trade/Device Name: InterFuse® Intervertebral Body Fusion Device Regulation Number: 21 CFR 888-3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 25, 2009 Received: November 27, 2009 .

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.

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

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Page 2 - Suresh Ghai, Ph.D.

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

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

510(k) Number (if known): _ Ko 93675 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 1 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 X (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)

signature

(Divisio : Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Vertebral Technologies, Inc. Vertebral Fechnologies, Into.
InterFuse Intervertebral Body Fusion Device Special 510(k), Pre-market Notthcarto 510(k) Number

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### 3. 510(k) SUMMARY

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

DEC 2 3 2009

| 510(k) Owner's Name: | Vertebral Technologies, Inc. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Address: | 5909 Baker Road, Suite 550<br>Minnetonka, MN 55345 |
| Phone/Fax/Email: | Office: [phone]<br>Company Main Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Name of Contact Person: | Suresh Ghai, Ph.D.<br>Director, Quality and Regulatory Affairs |
| Date prepared: | 25 NOV, 2009 |
| Trade or Proprietary Name: | InterFuse® Intervertebral Body Fusion Device |
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar<br>21 CFR § 888.3080<br>Product code: MAX<br>Device Class: Il |

## 3.1 LEGALLY MARKETED DEVICE TO WHICH YOUR FIRM IS CLAIMING EQUIVALENCE

The modified InterFuse® Intervertebral Body Fusion Device is substantially equivalent in performance, indication, design and material to VTI's own InterFuse® Intervertebral Body Fusion Device cleared under Premarket notification # K 080673.

#### 3.2 DEVICE DESCRIPTION

VTI's Intervertebral Body Fusion device is made of PEEK (Poly ether ether ketone), 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-ray and to aid in position retention when assembled in the disc space. 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 stop to or sior in the unjudent cogment with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as

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

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few as three segments to be used, although most patients will require between four and suction's and lew as three segments to be used, annough most politics. Each segment has a vertical slott segments for uptimatir coverage or the vertise and that will provide a path for solid Infough the belice for the Salgeon to mi With Bategis produced in four heights (8, 10, 12 and 14 bone grown during the foston process. " The (2011-11 and 25 mm) to fit a range of potential disc min) and two antenor-posicilion allifensity (is and 5 angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.

#### INTENDED USE OF THE DEVICE 3.5

The InterFuse® Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion The mien-ose "mervertional Body" dolly in degenerative disc disease (DDD) at one or two procedures in skelotally meters patisms finned as discogenic back pain with degeneration of the contiguous levels non E2-O1. DDD is doingraphic 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 intent use device in indication systems that have been cleared for use by the FDA in the lumbosacral spine.

# 3.6 TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

The modified InterFuse® Intervertebral Body Fusion Device is substantially equivalent in The modified interFuse "Intervettebral Body InterFuse Intervenebral Body Fusion Device periormance, moreador, booger and lease premarket notification # K080673 . The modified device hom our company (v r), occured andor promotive of the unmodified device (K080673).

# 3.7 SUMMARY AND CONCLUSIONS FROM THE NONCLINICAL TESTS SUBMITTED

The substantial equivalence is supported by bench testing comparing the modified InterFuse® Intervertebral Body Fusion Device to the predicate device (K080673).

The design of the device has not changed from the 510(k) cleared device (K080673). The only change is the expiry date/shelf life on the labels. The modified device has 2 years I he only change is the oxpily athe shelf-life of the unmodified device (K080673).

The two (2) years shelf-life is based on accelerated aging at 55℃ carried out per ASTM The two (2) your shalf-life, the packages were tested for seal integrity by F 1960-07. At the end of the 2-your enomine of the performance of the aged devices was peer lest, dye penchation and beberdance with ASTM F2077-03 - Test methods for Intervertebral Body Fusion Devices. The aged devices were also tested for cytotoxicity (ISO intervertebral Body Fusion Devices. The agon as not the acceptance criteria specified in the shelf-life testing protocol.

On the basis of performance data and packages testing it is concluded that the modified On the basio of pointly equivalent to the unmodified device (K080673).

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