ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)

K080615 · Titan Spine, LLC · MAX · Jun 17, 2008 · Orthopedic

Device Facts

• Record ID: K080615
• Device Name: ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
• Applicant: Titan Spine, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoskeleton TA® Interbody Fusion Device is indicated for use 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. Patients should have received 6 months of nonoperative treatment prior to treatment with the device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Device Story

Endoskeleton TA® Interbody Fusion Device; titanium alloy (Ti6Al4V-ELI) interbody implant; used for spinal fusion in skeletally mature patients with DDD; implanted by surgeons during spinal surgery; provides structural support to disc space to facilitate fusion; used with autograft bone and supplemental fixation; intended to alleviate discogenic back pain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Medical grade titanium alloy (Ti6Al4V-ELI) interbody fusion implant; variety of sizes to accommodate patient anatomy; used with associated instrumentation.

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 6 months prior nonoperative treatment. Used with autograft bone and supplemental 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

• BAK Interbody Fusion Device (P950002)
• Inter Fix Threaded Fusion Device (P970015)
• Ray Threaded Fusion Cage (P950019)
• Titan Spine Endoskeleton TA® VBR (K032812)

Submission Summary (Full Text)

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JUN 1 7 2008

# 7. 510(k) Summary according to 807.92(c)

| Contact: | Kevin Gemas<br>President<br>866-822-7800 | Titan Spine, LLC<br>Mequon Technology Center<br>10520 Baehr Rd., Suite A<br>Mequon, WI 53092 |
|-----------------|--------------------------------------------------|----------------------------------------------------------------------------------------------|
| Trade Name: | Endoskeleton TA® Interbody Fusion Device | |
| Product Class: | Class II | |
| Classification: | 21 CFR §888.3080 Orthosis, intervertebral fusion | |
| Product Codes: | MAX | |
| Panel Code: | 87 | |

#### Indications for Use:

The Endoskeleton TA® Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from 1.2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

#### Device Description:

The Endoskeleton TA® Interbody Fusion Device is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

#### Predicate Device(s):

The Endoskeleton TA® Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The four predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015) and the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Titan Spine Endoskeleton TA® VBR (K032812).

#### Performance Testing:

The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use.

K080615
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem of an eagle with outstretched wings, stylized with thick, bold lines. The eagle faces to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 1 7 2008

Titan Spinc, LLC % Silver Pine Consulting Mr. Richard Jansen President 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K080612

Trade/Device Name: Endoskeleton TA® Interbody Fusion Device Regulation Number: 21 CFR §888.3080 Regulation Name: Intervertebral body fusion device. Regulatory Class: Class II Product Code: MAX Dated: February 26, 2008 Received: April 22, 2008

Dear Mr. Jansen:

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 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.

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Page 2 - Mr. Richard Jansen

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 the reporting 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. Millerson

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

Enclosure

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K080615
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## 4. Statement of Indications for Use

510(k) Number (if known): _ Ko8 06 15

Indications for Use:

The Endoskeleton TA® Interbody Fusion Device is indicated for use 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. Patients should have received 6 months of nonoperative treatment prior to treatment with the device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Prescription Use V (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 OF NEEDED)

Nihrol fx mxm

Division of General, Restorative, and Neurological Devices

510(k) Number K080615

Concurrence of CDRH, Office of Device Evaluation (ODE)