ENDOSKELETON TC

K100889 · Titan Spine, LLC · ODP · Jul 29, 2010 · Orthopedic

Device Facts

• Record ID: K100889
• Device Name: ENDOSKELETON TC
• Applicant: Titan Spine, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jul 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.

Device Story

Endoskeleton® TC is a cervical intervertebral body fusion device; hollow titanium alloy (Ti6Al4V-ELI) cage; designed for implantation into cervical disc space. Device features internal cavity for autograft bone packing; includes windows for radiographic visualization of bone growth. Used by surgeons in clinical settings for spinal fusion procedures. Provides structural support to disc space; facilitates fusion; intended to alleviate discogenic pain. Mechanical performance validated via static/dynamic compression, shear, torsion, subsidence, and expulsion testing.

Clinical Evidence

Bench testing only. Performed static and dynamic axial compression, compression shear, and torsion per ASTM F2077; subsidence testing per ASTM F2267; and expulsion testing per FDA guidance.

Technological Characteristics

Material: Medical grade titanium alloy (Ti6Al4V-ELI). Form factor: Hollow cervical interbody cage with visualization windows. Mechanical testing standards: ASTM F2077 (compression, shear, torsion), ASTM F2267 (subsidence).

Indications for Use

Indicated for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) at one level (C3-C7). Requires 6 weeks prior non-operative treatment. Must be used with supplemental fixation and autograft bone.

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/C® Interbody Device (P980048)
• Phantom™ Plus Cage System (K082801)
• Zeus (K081614)
• Aesculap® CeSpace PEEK Spinal Implant System (K083311)

Submission Summary (Full Text)

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# 510(k) SUMMARY Titan Spine's Endoskeleton® TC

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Titan Spine, LLC Mequon Research Center 6140 W. Executive Drive, Suite A Mequon, WI 53092

Contact: Kevin Gemas Phone: [phone]

Date Prepared: March 30, 2010

# Name of Device and Name/Address of Sponsor

Endoskeleton® TC

Titan Spine, LLC Mequon Research Center 6140 W. Executive Drive, Suite A Mequon, WI 53092

#### Common or Usual Name

Intervertebral body fusion device

#### Classification Name

21 CFR §888.3080 Intervertebral body fusion device ODP Class II

# Device Description

The Endoskeleton® TC is a cervical intervertebral body fusion device. The system is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The center of the implant is hollow and is to be filled with autograft material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

JUL 2 9 2010

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# Predicate Devices

The Endoskeleton® TC was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include the BAK/C® Interbody Device by Zimmer Spine/Spine-Tech (P980048), the Phantom™ Plus Cage System by US Spine (K082801), the Zeus by Interbody Innovations (K081614), and the Aesculap® CeSpace PEEK Spinal Implant System (K083311).

#### Intended Use / Indications for Use

The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.

#### Summary of Non-Clinical Testing

The following mechanical testing was performed: static and dynamic axial compression, · static and dynamic compression shear, and static and dynamic torsion per ASTM F2077; subsidence testing per ASTM F2267; and expulsion testing as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. The preclinical testing performed indicated that the Endoskeleton® TC is adequate for the intended use.

#### Substantial Equivalence

The Endoskeleton® TC has the same intended use and substantially similar indications for use, technological characteristics and principles of operation as the identified predicate devices. There are no significant differences between the Endoskeleton® TC and other systems currently being marketed that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety or efficacy. Further, testing demonstrates substantially equivalent performance between the device and the predicates. Accordingly, the Endoskeleton® TC is substantially equivalent to the predicate devices in design, function, material, and intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is depicted in a simple, black-and-white design, and the text is in a sans-serif font.

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

Titan Spine, LLC % Hogan & Hartson, LLP John J. Smith, M.D., J.D. 555 13th Street, NW Washington, District of Columbia 20004

Re: K100889

Trade/Device Name: Endoskeleton® TC Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 28, 2010 Received: June 28, 2010

Dear Dr. Smith:

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

JUL 2 S 2010

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# Page 2 - John J. Smith, M.D., J.D.

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 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/ucm11.5809.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 vours.

Barbara Friend

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

Enclosure

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100889

# Indications for Use Statement

UUL 2 5 LUN

K100889 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Endoskeleton® TC

Indications for Use:

The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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